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A DDI Study of FDL169 and FDL176 in Healthy Subjects

Cystic Fibrosis Clinical Trial

Official title:
A Phase 1/2, Drug-Drug Interaction Study of FDL169 and FDL176 in Healthy Subjects and in Cystic Fibrosis Subjects Homozygous for the F508del-CFTR Mutation

Clinical Trial 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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03756922
Study type Interventional
Source Flatley Discovery Lab LLC
Contact
Status Suspended
Phase Phase 1/Phase 2
Start date November 27, 2018
Completion date February 2020
View Details
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