NCT03093714 is a Phase 1 clinical trial of FDL169 in Cystic Fibrosis, sponsored by Flatley Discovery Lab LLC.

Who is sponsoring NCT03093714?

NCT03093714 is sponsored by Flatley Discovery Lab LLC.

What drugs are being tested in NCT03093714?

Interventions in NCT03093714: FDL169, Placebo.

What condition does NCT03093714 study?

NCT03093714 studies Cystic Fibrosis.

Is NCT03093714 still recruiting?

NCT03093714 is currently completed. Last updated 12 April 2018.

Last reviewed 2018-04-12 · How we verify

NCT03093714

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Study to Evaluate Safety, PK and PD of FDL169 in Cystic Fibrosis Subjects

Completed Phase 1 Last updated 12 April 2018

What this trial tests

Phase 1 trial testing FDL169 in Cystic Fibrosis in 27 participants. Completed in 3 April 2018.

Timeline

23 August 2017

Primary endpoint
3 April 2018

3 April 2018

Quick facts

Lead sponsor	Flatley Discovery Lab LLC
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	27
Start date	23 August 2017
Primary completion	3 April 2018
Estimated completion	3 April 2018
Sites	14 locations across United Kingdom, Germany, Australia, Czechia

Drugs / interventions tested

FDL169 — full drug profile →
Placebo

Conditions studied

Cystic Fibrosis — all drugs for Cystic Fibrosis →

Sponsor

Flatley Discovery Lab LLC — full company profile →

Who can join

Adults 18 to 85, any sex, with Cystic Fibrosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a multicenter, randomized, placebo-controlled, dose-escalation study. Enrollment is planned to occur at approximately 14 global sites. Approximately 24 subjects with CF.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

CFTR Modulators: The Changing Face of Cystic Fibrosis in the Era of Precision Medicine.
Lopes-Pacheco M. · · 2019 · cited 349× · PMID 32153386 · DOI 10.3389/fphar.2019.01662
State of the Art on Approved Cystic Fibrosis Transmembrane Conductance Regulator (<i>CFTR</i>) Modulators and Triple-Combination Therapy.
Meoli A, Fainardi V, Deolmi M, Chiopris G, et al · · 2021 · cited 26× · PMID 34577628 · DOI 10.3390/ph14090928
Correctors (specific therapies for class II CFTR mutations) for cystic fibrosis.
Southern KW, Patel S, Sinha IP, Nevitt SJ. · · 2018 · cited 26× · PMID 30070364 · DOI 10.1002/14651858.cd010966.pub2
Emerging Cystic Fibrosis Transmembrane Conductance Regulator Modulators as New Drugs for Cystic Fibrosis: A Portrait of <i>in Vitro</i> Pharmacology and Clinical Translation.
Ghelani DP, Schneider-Futschik EK. · · 2020 · cited 23× · PMID 32259083 · DOI 10.1021/acsptsci.9b00060

Verify or expand the search:

Other trials of FDL169

Trials testing the same drug.

NCT03527095 — A Study to Compare the Pharmacokinetics of Different Oral Formulations of FDL169 in Healthy Subjects · Phase 1 · completed
NCT03424252 — An Phase 1 Study to Evaluate the Pharmacokinetic (PK) Profile of FDL169 New Formulations in Healthy Subjects · Phase 1 · completed

Other recruiting trials for Cystic Fibrosis

Currently open trials in the same condition.

NCT07437105 — Dose Escalation Study Evaluating the Safety and Pharmacokinetics of VX-272 in Healthy Participants · Phase 1 · recruiting
NCT07283770 — Dose Escalation Study Evaluating the Safety and Pharmacokinetics of VX-581 in Healthy Participants · Phase 1 · recruiting
NCT07274631 — A Cohort for Inflammatory Respiratory Diseases: From Phenotyping to Personalised Medicine · recruiting
NCT06810167 — Assessing Tenapanor as a Treatment of CF-related Constipation. · Phase 3 · recruiting
NCT06962852 — A Long-term Study to Monitor the Health Status of People With Cystic Fibrosis Who Took Part in a Previous Study With BI · Phase 1, PHASE2 · active not recruiting

Other Flatley Discovery Lab LLC trials

Trials by the same sponsor.

NCT03527095 — A Study to Compare the Pharmacokinetics of Different Oral Formulations of FDL169 in Healthy Subjects · Phase 1 · completed
NCT03516331 — A Drug-Drug Interaction Study of FDL169 and FDL176 in Healthy Subjects · Phase 1 · completed
NCT03424252 — An Phase 1 Study to Evaluate the Pharmacokinetic (PK) Profile of FDL169 New Formulations in Healthy Subjects · Phase 1 · completed
NCT03173573 — A Study to Assess the Safety, Tolerability and PK Profile of FDL176 in Healthy and CF Participants · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03093714 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Flatley Discovery Lab LLC
Last refreshed: 12 April 2018

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03093714.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing