neurological diseases progressive nervous system diseases
Conditions
Interventions
The volunteer will receive multiple doses of unlabeled PTC857 and a single dose
of 14C-labeled PTC857 as oral solutions using dosing syringes. The volunteer is
required to drink 240 mL water after e
Sponsors
PTC Therapeutics, Inc.
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. Healthy male participants between 18 and 65 years of age, inclusive, at Screening. 2. Body mass index (BMI) between 18.0 and 32.0 kg/m2, inclusive, and total body weight >=50 kg, at Screening and Check-In. 3. Participants must understand the nature of the study and must provide a signed and dated written informed consent before the conduct of any study-related procedures. 4. Male participants sexually active with women of childbearing potential who have not had a vasectomy must agree to use a barrier method of birth control from check-In until 90 days after discharge. Males must also refrain from sperm donations during this time period. 5. In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead electrocardiogram (ECG), vital sign measurements, and clinical laboratory evaluations (congenital nonhemolytic hyperbilirubinemia [eg, suspicion of Gilbert*s syndrome based on total and direct bilirubin] is not acceptable) at Screening and/or Check-In as assessed by the Investigator (or designee). 6. Willing and able to comply with the protocol. 7. History of on average 1 bowel movement per day (ie, no recent history of constipation and/or irregular bowel movement).
Exclusion criteria
Exclusion criteria: 1. Significant history or clinical manifestation of any metabolic, allergic, dermatologic, hepatic, renal, hematologic, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the Investigator (or designee). 2. History of significant hypersensitivity, intolerance, or allergy to sesame oil, gelatin (bovine and/or porcine), titanium dioxide, or red iron oxide, unless approved by the Investigator (or designee). 3. History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy and hernia repair are allowed). 4. History of alcohol or drug/chemical abuse within 2 years prior to Screening, or current evidence of substance dependence or self-reported alcoholic intake >21 units per week. One unit of alcohol equals 360 mL beer, 45 mL liquor, or 150 mL wine. 5. Positive drug screen at Screening or Check-In or positive alcohol screen at Check-In. 6. Use of tobacco- or nicotine-containing products within 1 month prior to Check-In, or positive cotinine screen at Screening or Check-In. A positive cotinine screen may be repeated once. 7. QT-interval corrected using Fridericia*s formula (QTcF) >=450 msec (based on the mean of triplicate measurements taken at Screening). Further criteria apply, see protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • To assess the rates and routes of excretion and calculate the mass balance of total radioactivity(TRA) following a single oral dose of 250 mg 14C-PTC857 containing ~3.7 MBq (100 µCi) TRA, during repeated PTC857 dosing*. • To assess the pharmacokinetics (PK) of TRA in whole blood and plasma following a single oral dose of 250 mg 14C-PTC857 containing ~3.7 MBq (100 µCi) TRA, during repeated PTC857 dosing*. • To assess the metabolite profiles and the distribution of 14C-PTC857 and its metabolite(s) in plasma, urine, and feces, following a single oral dose of 250 mg 14C-PTC857 containing ~3.7 MBq (100 µCi) TRA, during repeated PTC857 dosing*. *6 days of oral dosing with 250 mg PTC857 BID before, and 7 days of oral dosing with 250 mg PTC857 BID after the 14C-PTC857 dose. | — |
Secondary
| Measure | Time frame |
|---|---|
| • To assess the safety and tolerability of multiple oral doses of PTC857. | — |
Countries
Netherlands
Outcome results
None listed