A Phase 1 Study to Investigate the Absorption, Metabolism, and Excretion of PTC857 Following Oral Administration of a Single Dose of 14C-PTC857 at Steady-State Conditions in Healthy Male Volunteers.
- Conditions
- neurological diseasesprogressive nervous system diseases10029317
- Registration Number
- NL-OMON51552
- Lead Sponsor
- PTC Therapeutics, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 8
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).
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.
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(TRA) following a single oral dose of 250 mg<br /><br>14C-PTC857 containing ~3.7 MBq (100 µCi) TRA, during repeated PTC857 dosing*.<br /><br><br /><br>• To assess the pharmacokinetics (PK) of TRA in whole blood and plasma<br /><br>following a single oral dose of 250 mg 14C-PTC857 containing ~3.7 MBq (100 µCi)<br /><br>TRA, during repeated PTC857 dosing*.<br /><br><br /><br>• To assess the metabolite profiles and the distribution of 14C-PTC857 and its<br /><br>metabolite(s) in plasma, urine, and feces, following a single oral dose of 250<br /><br>mg 14C-PTC857 containing ~3.7 MBq (100 µCi) TRA, during repeated PTC857 dosing*.<br /><br><br /><br>*6 days of oral dosing with 250 mg PTC857 BID before, and 7 days of oral dosing<br /><br>with 250 mg PTC857 BID after the 14C-PTC857 dose. </p><br>
- Secondary Outcome Measures
Name Time Method <p>• To assess the safety and tolerability of multiple oral doses of PTC857.</p><br>