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This is a randomised, cross-over study comprised of 6 periods in healthy subjects.Subjects will receive Regimens A, B and C in a randomised crossover manner in the fed state, followed by Regimens D, E and F in a randomised crossover manner, in the fasted or fed state, as applicable.
This is a single centre, randomised, cross-over study comprised of 6 periods in healthy males and females.Subjects will receive Regimens A, B and C in a randomised crossover manner in the fed state, followed by Regimens D, E and F in a randomised crossover manner, in the fasted or fed state, as applicable.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Regimen A | Experimental | FDL169 200 mg reference tablet |
|
| Regimen B | Experimental | FDL169 200 mg testing tablet 1 |
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| Regimen C | Experimental | FDL169 200 mg testing tablet 2 |
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| Regimen D | Experimental | FDL169 200 mg testing tablet 1 or 2 with high fat diet |
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| Regimen E | Experimental | FDL169 200 mg testing tablet 1 or 2, fasted |
|
| Regimen F | Experimental | FDL169 200 mg testing tablet 1 or 2, with standard diet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FDL169 | Drug | CFTR corrector |
|
| Measure | Description | Time Frame |
|---|---|---|
| Relative bioavailability of FDL169 and its metabolites with different formulations | To determine the relative bioavailability of FDL169 and its metabolites M1 and M3, following different tablet formulations compared to a reference tablet | 17 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events | Safety and tolerability of FDL169 and its metabolites M1 and M3 , as determined by the incidence of adverse events (Aes) and serious adverse events (SAE)s. | 17 weeks |
| Pharmacokinetic parameters, Cmax |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Claudia Ordonez | Flatley Discovery Lab | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Quotient Sciences | Ruddington | Nottingham | NG11 6JS | United Kingdom |
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| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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The pharmacokinetic parameters of FDL169 and its metabolites M1 and M3 , maximal plasma concentration (Cmax)
| 17 weeks |
| Pharmacokinetic parameters, Tmax | The pharmacokinetic parameters of FDL169 and its metabolites M1 and M3; maximal concentration (Tmax) | 17 weeks |
| Pharmacokinetic parameters, AUC | The pharmacokinetic parameters of FDL169 and its metabolites M1 and M3; area under the plasma concentration curve (AUC) | 17 weeks |
| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |