An Phase 1 Study to Evaluate the Pharmacokinetic (PK) Profile of FDL169 New Formulations in Healthy Subjects
NCT03424252 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 11
Last updated 2018-11-02
Summary
Two parts, two periods, crossover study with part 2 is optional. In both parts, subjects will be randomized to sequentially receive both sublingual and oral formulations of FDL169.
Conditions
Interventions
- DRUG
-
FDL169
Cystic Fibrosis Transmembrane Regulator (CFTR) corrector
Sponsors & Collaborators
-
Flatley Discovery Lab LLC
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2017-12-18
- Primary Completion
- 2018-01-15
- Completion
- 2018-01-15
Countries
- United Kingdom
Study Locations
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