Trials / Completed
CompletedNCT04752540
A Phase I Study to Assess the Pharmacokinetics of Olorofim in Subjects With Hepatic Impairment
A Phase I, Single-dose, Parallel Group Study to Assess the Pharmacokinetics of Olorofim in Subjects With Hepatic Impairment
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 32 (actual)
- Sponsor
- F2G Biotech GmbH · Industry
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Accepted
Summary
A single oral dose study to investigate the PK and safety of olorofim in mild and moderately hepatically impaired subjects compared to subjects with normal hepatic function.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Olorofim | single oral dose |
Timeline
- Start date
- 2021-07-02
- Primary completion
- 2021-10-24
- Completion
- 2021-10-24
- First posted
- 2021-02-12
- Last updated
- 2022-03-16
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04752540. Inclusion in this directory is not an endorsement.