FDL169 ( DrugBank: FDL169 )
1 disease
| ID | Disease name (Link within this page) | Number of trials |
|---|---|---|
| 299 | Cystic fibrosis | 8 |
299. Cystic fibrosis
Clinical trials : 1,695 / Drugs : 1,527 - (DrugBank : 268) / Drug target genes : 111 - Drug target pathways : 174
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT03756922 (ClinicalTrials.gov) | November 27, 2018 | 27/11/2018 | A DDI Study of FDL169 and FDL176 in Healthy Subjects | 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 | Cystic Fibrosis | Drug: FDL169;Drug: FDL176 | Flatley Discovery Lab LLC | NULL | Suspended | 18 Years | 55 Years | All | 78 | Phase 1/Phase 2 | United Kingdom |
| 2 | NCT03527095 (ClinicalTrials.gov) | April 5, 2018 | 4/5/2018 | A Study to Compare the Pharmacokinetics of Different Oral Formulations of FDL169 in Healthy Subjects | A Phase 1, Open-label, Randomised, Cross Over Study to Compare the Pharmacokinetics of Different Oral Formulations of FDL169 in Healthy Subjects Following Single Doses | Cystic Fibrosis | Drug: FDL169 | Flatley Discovery Lab LLC | NULL | Completed | 18 Years | 55 Years | All | 11 | Phase 1 | United Kingdom |
| 3 | NCT03516331 (ClinicalTrials.gov) | March 7, 2018 | 24/4/2018 | A Drug-Drug Interaction Study of FDL169 and FDL176 in Healthy Subjects | A Phase 1, Open Label, Drug-Drug Interaction Study of FDL169 and FDL176 in Healthy Subjects | Cystic Fibrosis | Drug: FDL176 & FDL169 coadministration | Flatley Discovery Lab LLC | NULL | Completed | 18 Years | 55 Years | All | 16 | Phase 1 | United Kingdom |
| 4 | NCT03424252 (ClinicalTrials.gov) | December 18, 2017 | 31/1/2018 | An Phase 1 Study to Evaluate the Pharmacokinetic (PK) Profile of FDL169 New Formulations in Healthy Subjects | A Phase 1, Open-label, Crossover, Randomised Study to Evaluate the Pharmacokinetic Profile of FDL169 Sublingual Formulations in the Fed State in Healthy Subjects | Cystic Fibrosis | Drug: FDL169 | Flatley Discovery Lab LLC | NULL | Completed | 18 Years | 55 Years | All | 11 | Phase 1 | United Kingdom |
| 5 | NCT03093714 (ClinicalTrials.gov) | August 23, 2017 | 16/3/2017 | A Study to Evaluate Safety, PK and PD of FDL169 in Cystic Fibrosis Subjects | A Randomized, Double-Blind, Placebo-Controlled, Parallel Study to Evaluate Safety, Pharmacokinetics (PK) and Pharmacodynamics(PD) of FDL169 in Cystic Fibrosis (CF) Subjects Homozygous for the F508del-CFTR Mutation | Cystic Fibrosis | Drug: FDL169;Drug: Placebo | Flatley Discovery Lab LLC | NULL | Completed | 18 Years | 85 Years | All | 27 | Phase 1 | Australia;Czechia;Germany;United Kingdom |
| 6 | NCT02767297 (ClinicalTrials.gov) | April 2016 | 5/5/2016 | Bioavailability and Pharmacokinetics Study of FDL169 in Healthy Subjects and Subjects With Cystic Fibrosis | A Three-Part Phase 1b Bioavailability and Pharmacokinetics Study of Two Formulations of FDL169 in Healthy Subjects and Subjects With Cystic Fibrosis | Cystic Fibrosis | Drug: FDL169 | Flatley Discovery Lab LLC | NULL | Completed | 18 Years | N/A | Both | 46 | Phase 1/Phase 2 | United Kingdom |
| 7 | NCT02680418 (ClinicalTrials.gov) | December 2015 | 2/2/2016 | Pharmacokinetics of FDL169 in Healthy Female Subjects | A Phase I Dose Escalation Study to Assess the Pharmacokinetics (PK) of FDL169 in Healthy Female Volunteers | Cystic Fibrosis | Drug: FDL169 | Flatley Discovery Lab LLC | NULL | Completed | 18 Years | 55 Years | Female | 8 | Phase 1 | United Kingdom |
| 8 | NCT02359357 (ClinicalTrials.gov) | January 2015 | 13/1/2015 | FTIH - Single and Repeat Oral Doses of FDL169 in Healthy Volunteers | A Phase 1, Randomised, Double-Blind, Placebo-Controlled, Dose-Escalation First-Time-in-Human Study to Assess the Safety, Tolerability and Pharmacokinetic Profile of Single and Repeat Oral Doses of FDL169 in Healthy Volunteers | Cystic Fibrosis | Drug: FDL169;Drug: Placebo | Flatley Discovery Lab LLC | NULL | Completed | 18 Years | 45 Years | Male | 130 | Phase 1 | United Kingdom |