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Completed

NCT Number: NCT03408470

TD-1473 Absorption, Distribution, Metabolism and Excretion (ADME) Study in Healthy Male Subjects

This is an open-label, 2-cohort study to evaluate the absolute bioavailability, absorption, distribution, metabolism and excretion of TD-1473 in healthy male subjects. Subjects in cohort 1 will receive a single oral dose of TD-1473 and a single intravenous bolus dose of [14C]-TD-1473. Subjects in cohort 2 will receive a single oral dose of [14C]-TD-1473 only.

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Key information

Age range

19 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Celerion

Lincoln, Nebraska, 68502, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Subject is a healthy, nonsmoking male, 19 to 55 years old, inclusive
  • Subject has a body mass index (BMI) 19 to 32 kg/m2, inclusive, and weighs at least 50 kg
  • Subject is healthy as determined by the PI or designee based on medical history and physical examination performed at Screening and Day -1
  • Additional inclusion criteria apply

Exclusion criteria

  • Subject has any condition possibly affecting drug absorption (e.g., previous surgery on the gastrointestinal tract [including removal of parts of the stomach, bowel, liver, gall bladder, or pancreas])
  • Subject has a known hypersensitivity towards medications similar to TD 1473 or excipients contained in TD 1473
  • Subject regularly works with ionizing radiation or radioactive material
  • Subject has been exposed to ionizing radiations, within 1 year prior to the start of the study, as external irradiation (i.e., radiological examination including CT scan, excluding dental radiography) or internal radiation (i.e., diagnostic nuclear medicine procedure) or have participated in a radiolabeled study in the last 12 months
  • Subject, who, for any reason, is deemed by the PI or designee or Sponsor to be inappropriate for this study or have any condition which would confound or interfere with the evaluation of the safety, tolerability, and PK of the investigational drug or prevent compliance with the study protocol
  • Additional exclusion criteria apply

Treatment and study plan

TD-1473 oral capsule

Drug

(Intervention description included in arm description)

[14C]-TD-1473 IV bolus

Drug

(Intervention description included in arm description)

[14C]-TD-1473 Oral Capsule

Drug

(Intervention description included in arm description)

Primary outcomes

  1. Maximum observed concentration (Cmax) in Plasma

    Time frame: Up to 15 days

  2. Time to maximum observed concentration (tmax) in Plasma

    Time frame: Up to 15 days

  3. Area under the concentration-time curve from hour 0 to the last measurable concentration (AUC0-last) in Plasma

    Time frame: Up to 15 days

  4. Area under the concentration-time curve extrapolated to infinity (AUC0-inf) in Plasma

    Time frame: Up to 15 days

  5. Apparent terminal elimination half-life (t1/2) in Plasma

    Time frame: Up to 15 days

  6. Apparent clearance (Cl/F) in Plasma

    Time frame: Up to 15 days

  7. Apparent volume of distribution (Vz/F) in Plasma

    Time frame: Up to 15 days

  8. Absolute bioavailability (%F) in Plasma

    Time frame: Up to 15 days

Secondary outcomes

  1. Amount excreted in urine (Aeu) over the sampling interval in Urine

    Time frame: Up to 15 days

  2. Renal clearance (CLr) in Urine

    Time frame: Up to 15 days

  3. The percent excreted in urine (%Feu) in Urine

    Time frame: Up to 15 days

  4. Amount excreted in feces (Aef) over the sampling interval in Feces

    Time frame: Up to 15 days

  5. The percent excreted in feces (%Fef)

    Time frame: Up to 15 days

Other outcomes

  1. Metabolites in Plasma

    Time frame: Up to 15 days

    TD 1473 metabolite profiling will be performed in plasma containing sufficient amounts of radioactivity

  2. Metabolites in Urine

    Time frame: Up to 15 days

    TD 1473 metabolite profiling will be performed in urine containing sufficient amounts of radioactivity

  3. Metabolites in Feces

    Time frame: Up to 15 days

    TD-1473 metabolite profiling will be performed in feces containing sufficient amounts of radioactivity

Sponsors and collaborators

Lead sponsor

Theravance Biopharma

Industry

Registry information

Official study title

A 2-Cohort Study to Evaluate the Absolute Bioavailability, Absorption, Distribution, Metabolism and Excretion of TD-1473 Following an Intravenous and an Oral Dose of [14C]-TD-1473 in Healthy Male Subjects

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jan 24, 2018
Registry last updated
Jan 14, 2021

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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