Assessment of Varying Oral Dosing Regimens for F901318 in Healthy Subjects
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: A1; F901318 (10 days) F901318 : 10 days dosing orally |
Drug: F901318
F901318 tablet
|
| Experimental: A2; F901318 F901318 : 10 days dosing orally, alternative dosing regimen |
Drug: F901318
F901318 tablet
|
| Experimental: A3; F901318 F901318 : 10 days dosing orally, alternative dosing regimen |
Drug: F901318
F901318 tablet
|
| Experimental: A4; F901318 F901318 : 10 days dosing orally, alternative dosing regimen |
Drug: F901318
F901318 tablet
|
Outcome Measures
Primary Outcome Measures
- Incidence of treatment emergent adverse events [18 days]
safety and tolerability
Secondary Outcome Measures
- Area under the curve (AUC) 0-tau for F901318 [11 days]
Pharmacokinetics (PK) of oral doses of F90318
- maximum plasma concentration (Cmax) for F901318 [11 days]
PK of oral doses of F90318
- minimum plasma concentration (Cmin) for F901318 [11 days]
PK of oral doses of F90318
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Subjects will be males or females of any ethnic origin between 18 and 55 years of age, weighing between 60 and 100 kg, with a body mass index (BMI) between 18 and 30 kg/m2.
-
Subjects must be in good health, as determined by a medical history, physical examination, 12-lead electrocardiogram (ECG) and clinical laboratory evaluations (congenital non-haemolytic hyperbilirubinaemia is not acceptable)
-
Male subjects and female subjects of childbearing potential must agree to use appropriate contraception from screening, during the study and for 3 months after the last dose of study drug
Exclusion Criteria:
-
Female subjects who are pregnant or lactating.
-
Subjects who have received any prescribed systemic or topical medication (other than hormonal contraception or hormone replacement therapy) within 14 days of the dose administration unless in the opinion of the Investigator and the medical monitor the medication will not interfere with the study procedures or compromise safety.
-
Subjects who have used any non-prescribed systemic or topical medication (including herbal remedies) within 7 days of the dose administration (with the exception of vitamin/mineral supplements) unless in the opinion of the Investigator and the medical monitor the medication will not interfere with the study procedures or compromise safety.
-
Subjects who have received any medications, including St John's Wort, known to chronically alter drug absorption or elimination processes within 30 days of the dose administration unless in the opinion of the Investigator and the medical monitor the medication will not interfere with the study procedures or compromise safety.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Covance Clinical Research Unit | Leeds | West Yorkshire | United Kingdom |
Sponsors and Collaborators
- F2G Biotech GmbH
- Covance
Investigators
- Principal Investigator: Jim Bush, MB ChB PhD MRCS FFPM, Covance CRU Ltd
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- F901318-01-13-17