COVID infectie Acute Leukemia
Conditions
Interventions
Subject will be given 14C-PTC299 as an oral solution of 4 milliliters (mL)
using a syringe without a needle. Thereafter subject is also required to drink
an additional amount of 240 mL of water.
Th
Sponsors
PTC Therapeutics, Inc.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • To assess the rates and routes of excretion and calculate the mass balance of total radioactivity in urine and feces after a single oral dose of 16 mg/3.7 MBq of 14CPTC299 (day 7) which is preceded by 6 days of oral dosing of 16 mg/11.1 kBq 14C-PTC299 once daily. • To assess the pharmacokinetics PK of total radioactivity in plasma pools after 6 days of oral dosing of 16 mg/11.1 kBq 14C-PTC299 once daily (Day 6). • To assess the metabolite profiles and distribution of 14C-PTC299 and its metabolites in plasma, urine, and feces pools after 6 days of oral dosing of 16 mg/11.1 kBq 14C-PTC299 once daily (Day 6). | — |
Secondary
| Measure | Time frame |
|---|---|
| • To assess the PK of total radioactivity in whole blood and plasma after a single oral dose of 16 mg/3.7 MBq of 14C-PTC299 (day 7) which is preceded by 6 days of oral dosing of 16 mg/11.1 kBq 14C PTC299 once daily. • To assess the PK of 14C-PTC299 and its metabolites in plasma after a single oral dose of 16 mg/3.7 MBq of 14C-PTC299 which is preceded by 6 days of oral dosing of 16 mg/11.1 kBq 14CPTC299 once daily. • To assess the safety and tolerability of multiple oral doses of 16 mg 14C-PTC299 administered once daily for 7 days. | — |
Countries
Netherlands
Outcome results
None listed