Trials / Completed
CompletedNCT03340597
Assessment of Varying Oral Dosing Regimens for F901318 in Healthy Subjects
A Phase I, Open Label Study in Healthy Subjects to Evaluate the Safety, Tolerability and Pharmacokinetics of Varying Oral Dosing Regimens for F901318
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 45 (actual)
- Sponsor
- F2G Biotech GmbH · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
Summary
A Phase I, open label study evaluating safety, tolerability and pharmacokinetics of F901318 in healthy subjects following up to 28 days dosing, where F901318 is given orally . The effect of food upon the pharmacokinetics of F901318 and the effect of F901318 upon the pharmacokinetics of midazolam will also be assessed.
Detailed description
Each cohort will comprise 12 healthy subjects and cohorts A1 (A2), B1 and B2 will be conducted in a sequential manner such that the dose level can be optimised upon review of emerging safety, tolerability and PK data.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | F901318 | F901318 tablet |
Timeline
- Start date
- 2017-12-12
- Primary completion
- 2018-04-13
- Completion
- 2018-04-13
- First posted
- 2017-11-13
- Last updated
- 2018-08-02
Locations
1 site across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT03340597. Inclusion in this directory is not an endorsement.