A Phase 1 Study to Investigate the Absorption, Metabolism, and Excretion of 14C-PTC299 Following Multiple Oral Dose Administrations in Healthy Volunteers

Completed

• Conditions: COVID infectie; Acute Leukemia

• Registration Number: NL-OMON50826
• Lead Sponsor: PTC Therapeutics, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 7

Inclusion Criteria

1. Sex: male.
2. Age: 18 to 55 years, inclusive, at screening.
3. Body mass index: 18.0 to 30.0 kg/m2, inclusive.
4. Status: healthy subjects.
5. Subjects, if not surgically sterilized, must agree to use adequate
contraception and not donate sperm from admission to the clinical research
center until 90 days after discharge on Day 17. Adequate contraception for the
male subject (and his female partner) is defined as using hormonal
contraceptives or an intrauterine device combined with at least 1 of the
following forms of contraception: a diaphragm, a cervical cap, or a condom.
Total abstinence, in accordance with the lifestyle of the subject, is also
acceptable.

Exclusion Criteria

1. Employee of PRA Health Sciences (PRA) or the Sponsor.
2. History of relevant drug and/or food allergies.
3. Smoking more than 5 cigarettes, 1 cigar, or 1 pipe per day on average.
4. History of alcohol abuse or drug addiction (including soft drugs like
cannabis products).
5. Positive drug and alcohol screen (opiates, methadone, cocaine, amphetamines
[including ecstasy], cannabinoids, barbiturates, benzodiazepines, tricyclic
antidepressants, and alcohol) at screening or admission to the clinical
research center.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>• To assess the rates and routes of excretion and calculate the mass balance of<br /><br>total radioactivity in urine and feces after a single oral dose of 16 mg/3.7<br /><br>MBq of 14C­PTC299 (day 7) which is preceded by 6 days of oral dosing of 16<br /><br>mg/11.1 kBq 14C-PTC299 once daily.<br /><br>• To assess the pharmacokinetics PK of total radioactivity in plasma pools<br /><br>after 6 days of oral dosing of 16 mg/11.1 kBq 14C-PTC299 once daily (Day 6).<br /><br>• To assess the metabolite profiles and distribution of 14C-PTC299 and its<br /><br>metabolites in plasma, urine, and feces pools after 6 days of oral dosing of 16<br /><br>mg/11.1 kBq 14C-PTC299 once daily (Day 6). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>• To assess the PK of total radioactivity in whole blood and plasma after a<br /><br>single oral dose of 16 mg/3.7 MBq of 14C-PTC299 (day 7) which is preceded by 6<br /><br>days of oral dosing of 16 mg/11.1 kBq 14C PTC299 once daily.<br /><br>• To assess the PK of 14C-PTC299 and its metabolites in plasma after a single<br /><br>oral dose of 16 mg/3.7 MBq of 14C-PTC299 which is preceded by 6 days of oral<br /><br>dosing of 16 mg/11.1 kBq 14C­PTC299 once daily.<br /><br>• To assess the safety and tolerability of multiple oral doses of 16 mg<br /><br>14C-PTC299 administered once daily for 7 days.</p><br>