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Completed

NCT Number: NCT05873764

A Study to Learn About Effect of Sisunatovir in Healthy Adult Male Participants

The purpose of this clinical trial is to learn about the safety, effects, and tolerability of the study medicine (sisunatovir).

This study is looking for healthy adult participants who meet the following criteria:

1. Males age 18 to 55 years 2. All fertile participants must agree to the use of highly effective contraception 3. Body mass index (BMI) of 18 to 32.0 kg/m2; body weight of 55.0 to 100.0 kg. 4. Participants who are overtly healthy as determined by medical evaluation. This includes medical history, physical examination, blood pressure, pulse rate, standard 12-lead ECG (electrocardiogram), and laboratory tests.

This study will enroll up to 10 participants. All study participants will receive 1 dose of sisunatovir by mouth. The study duration is expected to be about 9 weeks. This includes a 28-day screening period, 16-day inpatient stay, and 2 overnight follow-up visits, if needed.

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Key information

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Pharmaron Clinical Pharmacology Center

Baltimore, Maryland, 21201, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

(key):

  • Males
  • Age 18- 55 years
  • Body mass index (BMI) 18.0 kg/m2 to 32.0 kg/m2
  • Body weight 55.0 kg to 100.0 kg
  • Considered to be in good health
  • Nonsmoker
  • Content of 14C in urine, whole blood, and/or plasma samples does not exceed the general environmental background level of 14C

Exclusion criteria

(key):

  • Clinically significant abnormal medical history or any abnormal finding on physical examination, vital signs, ECG, laboratory tests
  • History of cancer that has not been in full remission for >5 years
  • Acute illness within 14 days prior to Day 1
  • History of significant drug allergies
  • History or presence of alcohol or drug abuse
  • Recent history of incomplete bladder emptying with voiding or awakening more than once at night to void
  • Usual habit of <1 or >3 bowel movements per day
  • Exposure to radiation for therapeutic, diagnostic, or occupational reasons within the 12 months prior to Day 1.
  • Participation in another clinical study in which a [14C]-labeled drug was administered within 1 year prior to Check-in
  • Administration of another investigational medication within 60 days (or 5 half-lives, whichever is longer) prior to Day 1
  • Participation in an investigational-device study within 60 days prior to Day 1
  • Any ECG abnormality considered to be clinically significant by the Investigator
  • QTcF interval >450 msec and QRS interval >120 msec
  • Family history of long QT syndrome or of unexplained sudden death in a first-degree relative under 50 years of age
  • Documented congenital or acquired long QT syndrome
  • Presence of clinically significant hypertension
  • Presence of clinically significant hypotension
  • Loss or donation of more than 500 mL blood within 60 days prior to the Screening
  • Excessive consumption of alcohol
  • Use of any live vaccinations within 30 days
  • Use/consumption of food or drugs known to be moderate or strong cytochrome P450 3A4 (CYP3A4) inducers or potent CYP3A4 inhibitors within 14 days or 5 half-lives, whichever is longer, prior to RV521 administration

Treatment and study plan

200 mg RV521/78 µCi [ 14C]-RV521.

Drug

200 mg RV521/78 µCi [ 14C]-RV521

Primary outcomes

  1. Tmax (Time of maximum observed concentration)

    Time frame: Day 1 (time 0) to Day 29

    PK parameters of total radioactivity and RV521 following a single oral administration of [ 14C]-RV521 to healthy male subjects

  2. Cmax (Maximum observed concentration)

    Time frame: Day 1 (time 0) to Day 29

    PK parameters of total radioactivity and RV521 following a single oral administration of [ 14C]-RV521 to healthy male subjects

  3. AUC0-inf (Area under the concentration-time curve (AUC) extrapolated to infinity)

    Time frame: Day 1 (time 0) to Day 29

    PK parameters of total radioactivity and RV521 following a single oral administration of [ 14C]-RV521 to healthy male subjects

  4. AUC0-last (AUC from the time of dosing to the time of the last measurable concentration)

    Time frame: Day 1 (time 0) to Day 29

    PK parameters of total radioactivity and RV521 following a single oral administration of [ 14C]-RV521 to healthy male subjects

  5. lambdaz (Rate constant associated with the terminal elimination phase)

    Time frame: Day 1 (time 0) to Day 29

    PK parameters of total radioactivity and RV521 following a single oral administration of [ 14C]-RV521 to healthy male subjects

  6. t1/2 (half-life of the terminal elimination phase)

    Time frame: Day 1 (time 0) to Day 29

    PK parameters of total radioactivity and RV521 following a single oral administration of [ 14C]-RV521 to healthy male subjects

  7. CL/F (Apparent clearance of the drug from plasma after oral administration)

    Time frame: Day 1 (time 0) to Day 29

    PK parameters of total radioactivity and RV521 following a single oral administration of [ 14C]-RV521 to healthy male subjects

  8. Vz/F (Volume of distribution associated with the terminal phase)

    Time frame: Day 1 (time 0) to Day 29

    PK parameters of total radioactivity and RV521 following a single oral administration of [ 14C]-RV521 to healthy male subjects

  9. CLR (renal clearance)

    Time frame: Day 1 (time 0) to Day 29

    PK parameters of total radioactivity and RV521 following a single oral administration of [ 14C]-RV521 to healthy male subjects

  10. Fe (fraction of administered drug excreted into urine)

    Time frame: Day 1 (time 0) to Day 29

    PK parameters of total radioactivity and RV521 following a single oral administration of [ 14C]-RV521 to healthy male subjects

  11. Ae0-t (cumulative amount of 14C excreted into urine from time 0 to the last sampling interval)

    Time frame: Day 1 (time 0) to Day 29

    PK parameters of total radioactivity and RV521 following a single oral administration of [ 14C]-RV521 to healthy male subjects

  12. Ae0-t (Cumulative amount of 14C excreted into urine and feces from time 0 to the last sampling interval (in units of mass-equivalents/g))

    Time frame: Day 1 (time 0) to Day 29

    Mass balance parameters in urinary and fecal excretion of radioactivity

  13. Aet (Amount of 14C excreted into urine and feces per sampling interval (in units of mass-equivalents/g))

    Time frame: Day 1 (time 0) to Day 29

    Mass balance parameters in urinary and fecal excretion of radioactivity

  14. Fet (Fraction of 14C excreted into urine and feces per sampling interval (in units of %))

    Time frame: Day 1 (time 0) to Day 29

    Mass balance parameters in urinary and fecal excretion of radioactivity

  15. Fe0-t (Cumulative fraction of 14C excreted into urine or feces from time 0)

    Time frame: Day 1 (time 0) to Day 29

    Mass balance parameters in urinary and fecal excretion of radioactivity

  16. 14C associated with % of AUC of the total in plasma

    Time frame: Day 1 (time 0) to Day 29

    Metabolite Profiling and Identification

  17. 14C associated with % of administered dose of the total in urine and feces

    Time frame: Day 1 (time 0) to Day 29

    Metabolite Profiling and Identification

Secondary outcomes

  1. Spontaneously reported adverse events (AEs) during the Treatment Period

    Time frame: Day -1 to Day 29

    safety and tolerability of a single oral dose of RV521 in healthy male subjects

  2. Spontaneously reported serious AEs (SAEs) during the Treatment Period

    Time frame: Day -1 to Day 29

    Safety and tolerability of a single oral dose of RV521 in healthy male subjects

  3. Use of concomitant medications

    Time frame: Day -1 to Day 29

    Safety and tolerability of a single oral dose of RV521 in healthy male subjects

  4. Unscheduled assessments as needed for management of AEs

    Time frame: Day -1 to Day 29

    Safety and tolerability of a single oral dose of RV521 in healthy male subjects

  5. Clinically significant changes from baseline of any of the following: Vital Signs (blood pressure, heart rate [HR], respiratory rate [RR], and oral temperature)

    Time frame: Day -1 to Day 29

    Safety and tolerability of a single oral dose of RV521 in healthy male subjects

  6. Clinically significant changes from baseline of any of the following: 12-lead electrocardiogram (ECD) assessments

    Time frame: Day -1 to Day 29

    Safety and tolerability of a single oral dose of RV521 in healthy male subjects

  7. Clinically significant changes from baseline of any of the following: Physical examinations

    Time frame: Day -1 to Day 29

    Safety and tolerability of a single oral dose of RV521 in healthy male subjects

  8. Blood/Plasma AUC Ratio

    Time frame: Day 1 (time 0 to Day 29)

    AUC0-inf of total 14C in whole blood divided by the AUC0-inf of total 14C in plasma

  9. Amount of 14C excreted into nostrils per sampling interval (in units of mass-equivalents/g)

    Time frame: Day 1 (time 0) to Day 29

    Metabolite Profiling and Identification

  10. Cumulative amount of 14C excreted into nostrils, urine, and feces from time 0 to the last sampling interval (in units of mass-equivalents/g)

    Time frame: Day 1 (time 0 to Day 29)

    Metabolite Profiling and Identification

  11. Evaluation of total radioactivity in nasal samples following a single oral administration of [ 14C]-RV521 to healthy male subjects

    Time frame: Day 1 (time 0) to Day 29

    PK parameters of total radioactivity and RV521 following a single oral administration of [ 14C]-RV521 to healthy male subjects

  12. Structural identification of major metabolites

    Time frame: Day 1 (time 0) to Day 29

    Identification of each metabolite that accounts for ≥10% of circulating radiolabel

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

[14C] -RV521.HCl - A Phase 1, Open-label Study of the Absorption, Metabolism, and Excretion Following a Single Oral Dose in Healthy Male Subjects

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
May 24, 2023
Registry last updated
May 16, 2024

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.

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