Study Evaluating Pharmacokinetics and Mass Balance of [14C]-CTP-543 in Healthy Adult Male Volunteers

NCT04092712 | Completed Phase 1 FDA Drug

• 1 other identifier: CP543.1004
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

This study will assess the absorption, metabolism, excretion, mass balance, safety, and tolerability of a single oral administration of \[14C\]-CTP-543 in healthy male subjects.

Conditions

Healthy Volunteers

Keywords

Mass Balance; Radiolabeled; Pharmacokinetics

Outcome Measures

Primary Outcomes (18)

• Mass balance: Calculation of percent of total radioactivity recovered in urine

  From time zero up to 96 hours post-dose following oral administration of [14C]-CTP-543 up to Day 15

• Mass balance: Calculation of percent of total radioactivity recovered in feces

  From time zero up to 96 hours post-dose following oral administration of [14C]-CTP-543 up to Day 15

• CTP-543 PK: Cmax

  Maximum plasma concentration

  Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 96 hours post-dose

• CTP-543 PK: Tmax

  Time for Cmax

  Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 96 hours post-dose

• CTP-543 PK: t1/2

  Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 96 hours post-dose

• CTP-543 PK: AUClast

  Area under the plasma concentration time profile from time 0 to time of the last quantifiable concentration (Clast)

  Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 96 hours post-dose

• CTP-543 PK: AUCinf

  Area under the plasma concentration time profile from time 0 to infinity

  Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 96 hours post-dose

• CTP-543 PK: CL/F

  Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood (rate at which a drug is metabolized or eliminated by normal biological processes).

  Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 96 hours post-dose

• CTP-543 PK: Vz/F

  Apparent volume of distribution following oral administration

  Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 96 hours post-dose

• CTP-543 metabolite PK: Cmax

  Maximum plasma concentration

  Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 96 hours post-dose

• CTP-543 metabolite PK: Tmax

  Time for Cmax

  Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 96 hours post-dose

• CTP-543 metabolite PK: t1/2

  Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 96 hours post-dose

• CTP-543 metabolite PK: AUC0-last

  Area under the plasma concentration time profile from time 0 to time of the last quantifiable concentration (Clast)

  Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 96 hours post-dose

• CTP-543 metabolite PK: AUCinf

  Area under the plasma concentration time profile from time 0 to infinity

  Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 96 hours post-dose

• Total [14C]: urine

  Total radioactivity excreted into the urine from time zero to the time of last measurable concentration following oral administration of \[14C\]-CTP-543

  Pre-dose up to 336 hours post-dose

• Total [14C]: feces

  Total radioactivity excreted into the feces from time zero to the time of last measurable concentration following oral administration of \[14C\]-CTP-543

  Pre-dose up to 336 hours post-dose

• Total radioactivity in whole blood

  Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours post-dose

• Total radioactivity in plasma

  Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours post-dose

Secondary Outcomes (13)

• Adverse events

  Screening up to Day 15

• Number of Participants With Clinically Significant Change From Baseline in Heart Rate

  Screening, Pre-dose, 2, 8, 48 hours post-dose

• Number of Participants With Clinically Significant Change From Baseline in Blood Pressure

  Screening, Pre-dose, 2, 8, 48 hours post-dose

• Number of Participants With Clinically Significant Change From Baseline in Respiratory Rate

  Screening, Pre-dose, 2, 8, 48 hours post-dose

• Number of Participants With Clinically Significant Change From Baseline in Temperature

  Screening, Pre-dose, 2, 8, 48 hours post-dose

Study Arms (1)

Investigational Product

EXPERIMENTAL

\[14C\]-CTP-543

Drug: [14C]-CTP-543

Interventions

[14C]-CTP-543 DRUG

Single dose of radiolabeled CTP-543 (approximately 75 μCi) administered as an oral solution

Investigational Product

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male subjects between the ages of 19 and 55 years, inclusive (healthy is determined by medical evaluation, including medical history, full physical examination, vital signs, electrocardiogram, and clinical laboratory tests)
• Body Mass Index of 18.0 to 32.0 kg/m2
• Continuous non smoker who has not used nicotine containing products for at least 3 months prior to dosing and throughout the study

You may not qualify if:

• Known immunodeficiency disorder, including positive serology for human immunodeficiency virus (HIV) at screening
• Infection with hepatitis B or hepatitis C viruses
• History of irregular bowel movements
• History of herpes zoster
• A positive tuberculosis test at screening or history of incompletely treated or untreated tuberculosis
• History or presence of alcoholism or drug abuse within the past 2 years prior to dosing
• Participation in another clinical study within 30 days prior to dosing

Sponsors & Collaborators

• Concert Pharmaceuticals: lead
• Celerion: collaborator

Study Sites (1)

Celerion

Lincoln, Nebraska, 68502, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2019
• First Posted: September 17, 2019
• Study Start: September 5, 2019
• Primary Completion: September 11, 2019
• Study Completion: September 20, 2019
• Last Updated: September 25, 2019

Record last verified: 2019-09

Locations

US (1)