A Phase I Study to Assess the Pharmacokinetics of Olorofim in Subjects With Renal Impairment
NCT05200286 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16
Last updated 2023-01-20
Summary
A single oral dose study to investigate the PK and safety of olorofim in subjects with severe renal impairment compared to subjects with normal renal function.
Conditions
- Renal Impairment
Interventions
- DRUG
-
Olorofim
Single oral dose
Sponsors & Collaborators
-
F2G Biotech GmbH
lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- OTHER
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2022-02-10
- Primary Completion
- 2022-12-13
- Completion
- 2022-12-13
- FDA Drug
- Yes
Countries
- United States
Study Locations
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