A Trial to Study the Absorption, Metabolism, and Excretion of [14C]-Olinciguat in Healthy Male Volunteers
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 4/5/2019 |
| Start Date: | January 17, 2019 |
| End Date: | February 27, 2019 |
A Phase 1, Open-label Study of the Absorption, Metabolism, and Excretion of [14C]-Olinciguat ([14C]-IW-1701) Following a Single Oral Dose in Healthy Male Subjects
The primary objective is to characterize the pharmacokinetics (PK) of olinciguat and total
radioactivity and to assess the elimination of total radioactivity from a single oral dose of
[14C]-olinciguat.
radioactivity and to assess the elimination of total radioactivity from a single oral dose of
[14C]-olinciguat.
OLI-103 is a Phase 1 open-label, nonrandomized, single-dose study in up to 8 subjects that
will be conducted at a single center in the US. Safety assessments will be performed
throughout the clinic period and multiple PK samples will be collected. Subjects will be
confined to the clinical research center for at least 8 days.
The purpose of the study is to determine the absorption, metabolism, and excretion of
[14C]-olinciguat and to characterize and determine, where possible, the metabolites present
in plasma, urine, and feces after a single oral dose. The study will help identify and
characterize olinciguat metabolites, evaluate the likelihood of effects of liver or kidney
impairment on the disposition of olinciguat, and assess the likelihood of drug-drug
interactions with olinciguat.
will be conducted at a single center in the US. Safety assessments will be performed
throughout the clinic period and multiple PK samples will be collected. Subjects will be
confined to the clinical research center for at least 8 days.
The purpose of the study is to determine the absorption, metabolism, and excretion of
[14C]-olinciguat and to characterize and determine, where possible, the metabolites present
in plasma, urine, and feces after a single oral dose. The study will help identify and
characterize olinciguat metabolites, evaluate the likelihood of effects of liver or kidney
impairment on the disposition of olinciguat, and assess the likelihood of drug-drug
interactions with olinciguat.
Inclusion Criteria:
- Males of any race, between 18 and 55 years of age, inclusive
- Body mass index between 18 and 32 kg/m2, inclusive
- Subject is in good health and has no clinically significant findings on physical
examination
- Men must agree to use protocol-specified contraception and also to not donate sperm
throughout the study and for at least 90 days after the final dose of study drug
Exclusion Criteria:
- Any active or unstable clinically significant medical condition
- Use of any prescribed or non-prescribed medication
Additional inclusion/exclusion criteria may apply per protocol
We found this trial at
1
site
Click here to add this to my saved trials
