Skip to main content
OpenTrials
Completed

NCT Number: NCT06309394

A Study Assessing the Mass Balance, Pharmacokinetics, and Metabolite Profiles of a Single Oral Dose of [14C]INCB099280 in Healthy Male Participants

This study is being conducted to assess the Mass Balance, Pharmacokinetics, and Metabolite Profiles of a Single Oral Dose of [14C]INCB099280 in Healthy Male Participants.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy Participants

Age range

35 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Quotient Sciences Ltd

Nottingham, NG11 6JS, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Ability to comprehend and willingness to sign a written ICF for the study.
  • Healthy males, as determined by the investigator based upon physical examinations, ECGs, vital signs, and safety laboratory assessments, aged 35 to 55 years, inclusive, at the time of signing the ICF.
  • Body mass index between 18.0 and 32.0 kg/m2, inclusive, at the time of screening.
  • No clinically significant findings in screening evaluations (eg, clinical, laboratory, vital signs, and ECG) at screening and Day -1.
  • Ability to swallow and retain oral medication.

Exclusion criteria

  • History of clinically significant respiratory, renal, gastrointestinal, endocrine, hematopoietic, psychiatric, and/or neurological disease as judged by the investigator.
  • History of cardiovascular, cerebrovascular, peripheral vascular, or thrombotic disease or uncontrolled hypertension (systolic blood pressure > 140 mm Hg or diastolic blood pressure > 90 mmHg at screening, confirmed by repeat testing).
  • Presence of a malabsorption syndrome (eg, Crohn's disease or chronic pancreatitis) that could possibly affect drug absorption.
  • Current or recent (within 6 months before screening), clinically significant, gastrointestinal disease or surgery (including cholecystectomy, excluding appendectomy) that could affect the absorption of study drug.
  • Any major surgery within 6 months of screening.
  • Donation of blood to a blood bank or in a clinical study (except a screening visit) within 3 months before screening (within 2 weeks for plasma donation).
  • Positive test for HBV, HCV, or HIV at screening. Participants whose HBV results are compatible with prior immunization or immunity due to infection may be included at the discretion of the investigator.
  • Regular alcohol consumption > 21 units per week (1 unit = 8 oz of beer or a 25-mL shot of a 40% spirit; 1.5 to 2 units = a 125-mL glass of wine, depending on type).
  • Positive breath test for alcohol or positive urine screen for drugs of abuse (confirmed by repeat) at screening or admission (Day -1).
  • Treatment with another investigational medication within 90 days or 5 half-lives (whichever is longer) before Day 1 or current enrollment in another investigational drug study.
  • Participation in any clinical study involving a 14C-radiolabeled investigational product within 12 months prior to admission (Day -1).
  • Radiation exposure, including that from the present study, excluding background radiation but including diagnostic x-rays and other medical exposures, exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 2017, shall participate in the study.
  • History of tobacco- or nicotine-containing product use within 1 month before screening. Consumption of tobacco- or nicotine-containing products 72 hours before admission (Day -1) until CRU discharge is not permitted. Breath test for carbon monoxide > 10 ppm (confirmed by repeat) at screening or admission (Day -1).
  • Use of prescription drugs within 14 days before Day 1 or nonprescription medications/products (including vitamins, minerals, and phytotherapeutic, herbal, or plant-derived preparations) within 7 days before Day 1 until CRU discharge. However, paracetamol up to 4000 mg Q24H and ibuprofen up to 600 mg Q24H are permitted.

Other protocol-defined Inclusion/Exclusion Criteria may apply.

Treatment and study plan

INCB099280

Drug

INCB099280 will be administered orally, followed approximately 10 minutes later by an oral dose solution of radiolabeled INCB099280.

Primary outcomes

  1. Total Recovery (Urine + Feces) of the Administered Radioactivity

    Time frame: 264 hours in urine; 408 hours in feces

    Radioactivity in urine and feces was reported as the percentage of the administered radioactivity excreted.

Secondary outcomes

  1. Abundance of INCB099280 Detected in Plasma

    Time frame: 0 hours (predose) and up to 24 hours post-dose

    Plasma samples for metabolism investigations were obtained at 0, 1, 2, 4, 8, 12, 16, and 24 hours post-dose and were pooled across participants at each timepoint. TRPA=total radioactive peak area. The reported values are single measurements of pooled plasma or fecal samples; therefore, no statistical analysis is possible, and data have been reported with a measure type of "number."

  2. Abundance of INCB099280 Metabolites Detected in Feces

    Time frame: 0 hours (predose) and up to 96 hours post-dose

    Homogenized fecal samples from individual participants were pooled for each collection interval by taking a fixed percentage of the total amount excreted from each collection interval/participant. The reported values are single measurements of pooled plasma or fecal samples; therefore, no statistical analysis is possible, and data have been reported with a measure type of "number."

  3. Cmax of INCB099280

    Time frame: 0 hours (predose) and 0.5, 1, 2, 4, 6, 8, 12, and 16 hours post-dose (Day 1); 24 and 36 hours post-dose (Day 2); 48 hours post-dose (Day 3), 72 hours post-dose (Day 4), 96 hours post-dose (Day 5), 120 hours post-dose (Day 6)

    Cmax was defined as the maximum observed plasma or serum concentration of INCB099280.

  4. Tmax of INCB099280

    Time frame: 0 hours (predose) and 0.5, 1, 2, 4, 6, 8, 12, and 16 hours post-dose (Day 1); 24 and 36 hours post-dose (Day 2); 48 hours post-dose (Day 3), 72 hours post-dose (Day 4), 96 hours post-dose (Day 5), 120 hours post-dose (Day 6)

    tmax was defined as the time to the maximum concentration of INCB099280.

  5. AUC0-t of INCB099280

    Time frame: 0 hours (predose) and 0.5, 1, 2, 4, 6, 8, 12, and 16 hours post-dose (Day 1); 24 and 36 hours post-dose (Day 2); 48 hours post-dose (Day 3), 72 hours post-dose (Day 4), 96 hours post-dose (Day 5), 120 hours post-dose (Day 6)

    AUC0-t was defined as the area under the steady-state plasma or serum concentration-time curve up to the last measurable concentration of INCB099280.

  6. AUC0-∞ of INCB099280

    Time frame: 0 hours (predose) and 0.5, 1, 2, 4, 6, 8, 12, and 16 hours post-dose (Day 1); 24 and 36 hours post-dose (Day 2); 48 hours post-dose (Day 3), 72 hours post-dose (Day 4), 96 hours post-dose (Day 5), 120 hours post-dose (Day 6)

    AUC0-∞ was defined as the area under the single-dose plasma or serum concentration-time curve extrapolated to time of infinity.

  7. t½ of INCB099280

    Time frame: 0 hours (predose) and 0.5, 1, 2, 4, 6, 8, 12, and 16 hours post-dose (Day 1); 24 and 36 hours post-dose (Day 2); 48 hours post-dose (Day 3), 72 hours post-dose (Day 4), 96 hours post-dose (Day 5), 120 hours post-dose (Day 6)

    t½ was defined as the apparent terminal-phase disposition half-life of INCB099280.

  8. CL/F of INCB099280

    Time frame: 0 hours (predose) and 0.5, 1, 2, 4, 6, 8, 12, and 16 hours post-dose (Day 1); 24 and 36 hours post-dose (Day 2); 48 hours post-dose (Day 3), 72 hours post-dose (Day 4), 96 hours post-dose (Day 5), 120 hours post-dose (Day 6)

    CL/F was defined as the apparent oral dose clearance of INCB099280.

  9. Vz/F of INCB099280

    Time frame: 0 hours (predose) and 0.5, 1, 2, 4, 6, 8, 12, and 16 hours post-dose (Day 1); 24 and 36 hours post-dose (Day 2); 48 hours post-dose (Day 3), 72 hours post-dose (Day 4), 96 hours post-dose (Day 5), 120 hours post-dose (Day 6)

    Vz/F was defined as the maximum observed plasma or serum concentration of INCB099280.

  10. Cmax of Total Radioactivity in Blood

    Time frame: 0 hours (predose) and 0.5, 1, 2, 4, 6, 8, 12, and 16 hours post-dose (Day 1); 24 and 36 hours post-dose (Day 2); 48 hours post-dose (Day 3), 72 hours post-dose (Day 4), 96 hours post-dose (Day 5), 120 hours post-dose (Day 6)

    Cmax was defined as the maximum observed concentration of total radioactivity in blood. Additional samples were collected every 24 hours until discharge (up to 264 hours).

  11. Tmax of Total Radioactivity in Blood

    Time frame: 0 hours (predose) and 0.5, 1, 2, 4, 6, 8, 12, and 16 hours post-dose (Day 1); 24 and 36 hours post-dose (Day 2); 48 hours post-dose (Day 3), 72 hours post-dose (Day 4), 96 hours post-dose (Day 5), 120 hours post-dose (Day 6)

    tmax was defined as the time to the maximum concentration of total radioactivity in blood. Additional samples were collected every 24 hours until discharge (up to 264 hours).

  12. AUC0-t of Total Radioactivity in Blood

    Time frame: 0 hours (predose) and 0.5, 1, 2, 4, 6, 8, 12, and 16 hours post-dose (Day 1); 24 and 36 hours post-dose (Day 2); 48 hours post-dose (Day 3), 72 hours post-dose (Day 4), 96 hours post-dose (Day 5), 120 hours post-dose (Day 6)

    AUC0-t was defined as the area under the steady-state plasma or serum concentration-time curve up to the last measurable concentration of total radioactivity in blood. Additional samples were collected every 24 hours until discharge (up to 264 hours).

  13. AUC0-∞ of Total Radioactivity in Blood

    Time frame: 0 hours (predose) and 0.5, 1, 2, 4, 6, 8, 12, and 16 hours post-dose (Day 1); 24 and 36 hours post-dose (Day 2); 48 hours post-dose (Day 3), 72 hours post-dose (Day 4), 96 hours post-dose (Day 5), 120 hours post-dose (Day 6)

    AUC0-∞ was defined as the area under the single-dose plasma or serum concentration-time curve extrapolated to time of infinity. Additional samples were collected every 24 hours until discharge (up to 264 hours).

  14. t½ of Total Radioactivity in Blood

    Time frame: 0 hours (predose) and 0.5, 1, 2, 4, 6, 8, 12, and 16 hours post-dose (Day 1); 24 and 36 hours post-dose (Day 2); 48 hours post-dose (Day 3), 72 hours post-dose (Day 4), 96 hours post-dose (Day 5), 120 hours post-dose (Day 6)

    t½ was defined as the apparent terminal-phase disposition half-life of total radioactivity in blood. Additional samples were collected every 24 hours until discharge (up to 264 hours).

  15. CL/F of Total Radioactivity in Blood

    Time frame: 0 hours (predose) and 0.5, 1, 2, 4, 6, 8, 12, and 16 hours post-dose (Day 1); 24 and 36 hours post-dose (Day 2); 48 hours post-dose (Day 3), 72 hours post-dose (Day 4), 96 hours post-dose (Day 5), 120 hours post-dose (Day 6)

    CL/F was defined as the apparent oral dose clearance of total radioactivity in blood. Additional samples were collected every 24 hours until discharge (up to 264 hours).

  16. Vz/F of Total Radioactivity in Blood

    Time frame: 0 hours (predose) and 0.5, 1, 2, 4, 6, 8, 12, and 16 hours post-dose (Day 1); 24 and 36 hours post-dose (Day 2); 48 hours post-dose (Day 3), 72 hours post-dose (Day 4), 96 hours post-dose (Day 5), 120 hours post-dose (Day 6)

    Vz/F was defined as the maximum observed plasma or serum concentration of total radioactivity in blood. Additional samples were collected every 24 hours until discharge (up to 264 hours).

  17. Cmax of Total Radioactivity in Plasma

    Time frame: 0 hours (predose) and 0.5, 1, 2, 4, 6, 8, 12, and 16 hours post-dose (Day 1); 24 and 36 hours post-dose (Day 2); 48 hours post-dose (Day 3), 72 hours post-dose (Day 4), 96 hours post-dose (Day 5), 120 hours post-dose (Day 6)

    Cmax was defined as the maximum observed concentration of total radioactivity in plasma. Additional samples were collected every 24 hours until discharge (up to 264 hours).

  18. Tmax of Total Radioactivity in Plasma

    Time frame: 0 hours (predose) and 0.5, 1, 2, 4, 6, 8, 12, and 16 hours post-dose (Day 1); 24 and 36 hours post-dose (Day 2); 48 hours post-dose (Day 3), 72 hours post-dose (Day 4), 96 hours post-dose (Day 5), 120 hours post-dose (Day 6)

    tmax was defined as the time to the maximum concentration of total radioactivity in plasma. Additional samples were collected every 24 hours until discharge (up to 264 hours).

  19. AUC0-t of Total Radioactivity in Plasma

    Time frame: 0 hours (predose) and 0.5, 1, 2, 4, 6, 8, 12, and 16 hours post-dose (Day 1); 24 and 36 hours post-dose (Day 2); 48 hours post-dose (Day 3), 72 hours post-dose (Day 4), 96 hours post-dose (Day 5), 120 hours post-dose (Day 6)

    AUC0-t was defined as the area under the steady-state plasma or serum concentration-time curve up to the last measurable concentration of total radioactivity in plasma. Additional samples were collected every 24 hours until discharge (up to 264 hours).

  20. AUC0-∞ of Total Radioactivity in Plasma

    Time frame: 0 hours (predose) and 0.5, 1, 2, 4, 6, 8, 12, and 16 hours post-dose (Day 1); 24 and 36 hours post-dose (Day 2); 48 hours post-dose (Day 3), 72 hours post-dose (Day 4), 96 hours post-dose (Day 5), 120 hours post-dose (Day 6)

    AUC0-∞ was defined as the area under the single-dose plasma or serum concentration-time curve extrapolated to time of infinity. Additional samples were collected every 24 hours until discharge (up to 264 hours).

  21. t½ of Total Radioactivity in Plasma

    Time frame: 0 hours (predose) and 0.5, 1, 2, 4, 6, 8, 12, and 16 hours post-dose (Day 1); 24 and 36 hours post-dose (Day 2); 48 hours post-dose (Day 3), 72 hours post-dose (Day 4), 96 hours post-dose (Day 5), 120 hours post-dose (Day 6)

    t½ was defined as the apparent terminal-phase disposition half-life of total radioactivity in plasma. Additional samples were collected every 24 hours until discharge (up to 264 hours).

  22. CL/F of Total Radioactivity in Plasma

    Time frame: 0 hours (predose) and 0.5, 1, 2, 4, 6, 8, 12, and 16 hours post-dose (Day 1); 24 and 36 hours post-dose (Day 2); 48 hours post-dose (Day 3), 72 hours post-dose (Day 4), 96 hours post-dose (Day 5), 120 hours post-dose (Day 6)

    CL/F was defined as the apparent oral dose clearance of total radioactivity in plasma. Additional samples were collected every 24 hours until discharge (up to 264 hours).

  23. Vz/F of Total Radioactivity in Plasma

    Time frame: 0 hours (predose) and 0.5, 1, 2, 4, 6, 8, 12, and 16 hours post-dose (Day 1); 24 and 36 hours post-dose (Day 2); 48 hours post-dose (Day 3), 72 hours post-dose (Day 4), 96 hours post-dose (Day 5), 120 hours post-dose (Day 6)

    Vz/F was defined as the maximum observed plasma or serum concentration of total radioactivity in plasma. Additional samples were collected every 24 hours until discharge (up to 264 hours).

  24. Number of Participants With Any Treatment-emergent Adverse Event (TEAE)

    Time frame: up to Day 22

    An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE could be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug.

Sponsors and collaborators

Lead sponsor

Incyte Corporation

Industry

Registry information

Official study title

An Open-Label Study Assessing the Mass Balance, Pharmacokinetics, and Metabolite Profiles of a Single Oral Dose of [14C]INCB099280 in Healthy Male Participants

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Mar 13, 2024
Registry last updated
Sep 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.