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

Healthy Volunteers Clinical Trial

Official title:

A Phase 1, Open-label Study to Assess the Absorption, Metabolism, Excretion, and Mass Balance of Oral [14C]-CTP-543 in Healthy Adult Male Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04092712
• Other study ID #: CP543.1004
• Status: Completed
• Phase: Phase 1
• Start date: September 5, 2019
• Est. completion date: September 20, 2019

Study information

• Verified date: September 2019
• Source: Concert Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: September 20, 2019
• Est. primary completion date: September 11, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years to 55 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• [14C]-CTP-543
Single dose of radiolabeled CTP-543 (approximately 75 µCi) administered as an oral solution

Locations

Country	Name	City	State
United States	Celerion	Lincoln	Nebraska

Sponsors (2)

Lead Sponsor	Collaborator
Concert Pharmaceuticals	Celerion

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	CTP-543 PK: t1/2		Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 96 hours post-dose
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Adverse events	Number of adverse events, which are any untoward medical occurrence regardless of attribution to study drug in a participant who received study drug	Screening up to Day 15
Secondary	Number of Participants With Clinically Significant Change From Baseline in Heart Rate	Heart rate measured in beats per minute (bpm)	Screening, Pre-dose, 2, 8, 48 hours post-dose
Secondary	Number of Participants With Clinically Significant Change From Baseline in Blood Pressure	Blood pressure measured in millimeters of mercury (mmHg)	Screening, Pre-dose, 2, 8, 48 hours post-dose
Secondary	Number of Participants With Clinically Significant Change From Baseline in Respiratory Rate	Respiratory rate measured in breaths per minute	Screening, Pre-dose, 2, 8, 48 hours post-dose
Secondary	Number of Participants With Clinically Significant Change From Baseline in Temperature	Temperature measured in Celsius (°C)	Screening, Pre-dose, 2, 8, 48 hours post-dose
Secondary	Number of Participants With Clinically Significant Change From Baseline in Hematology		Screening, Check-in, 8, 24 hours postdose
Secondary	Number of Participants With Clinically Significant Change From Baseline in Serum Chemistry		Screening, Check-in, 8, 24 hours postdose
Secondary	Number of Participants With Clinically Significant Change From Baseline in Coagulation		Screening, Check-in, 8, 24 hours postdose
Secondary	Number of Participants With Clinically Significant Change From Baseline in Urinalysis		Screening, Check-in, 8, 24 hours postdose
Secondary	Number of Participants With Clinically Significant Changes to the Physical Examination	Clinically significant changes to the physical examination	Screening up to Day 15
Secondary	Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram - P Wave		Screening, Pre-dose, 48 hours post-dose
Secondary	Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram - QRS Complex		Screening, Pre-dose, 48 hours post-dose
Secondary	Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram - QT Interval		Screening, Pre-dose, 48 hours post-dose