https://clinicaltrials.gov/ct2/show/NCT03756922
Sponsor:
Flatley Discovery Lab LLC
Information provided by (Responsible Party):
Flatley Discovery Lab LLC
Brief Summary:
A DDI study to assess the safety, tolerability and pharmacokinetics of both; doses of FDL176 with and without co-administration of FDL169 and doses of FDL169 with and without co-administration of FDL176.
Condition or disease Intervention/treatment Phase
Cystic Fibrosis
Drug: FDL169
Drug: FDL176
Phase 1
Detailed Description:
This is an open-label, non-randomised study. Enrolment will be in two parallel and independent parts. Part 1 will assess the safety, tolerability and pharmacokinetics of single doses of FDL176 with and without co-administration of FDL169. Part 2 will assess the safety, tolerability and pharmacokinetics of repeated doses of FDL169 with and without co-administration of FDL176.
Study Design
Study Type : Interventional (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, Open Label, Drug-Drug Interaction Study of FDL169 and FDL176 in Healthy Subjects
Actual Study Start Date : November 27, 2018
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2019