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| ID | Type | Description | Link |
|---|---|---|---|
| RD 674/25728 | Other Identifier | Sponsor |
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To determine the safety and tolerability of single and multiple escalating doses of FDL169 in healthy male subjects.
This study is the first time in human study and consists of two parts.
Part 1A:
Part 1 of the study is a randomised, double-blind, placebo-controlled, dose-escalation, first-time-in-human study to assess the safety, tolerability and PK profiles following single oral administrations of FDL169 to healthy male volunteers. Sixty-four (64) male subjects (8 per cohort) will be included in Part 1 of the study. Up to eight dose levels of FDL169 are planned to be tested in Part 1 of the study.
Part 1B:
Open label. Following completion of Part 1A of the study, an additional cohort of 8 subjects will receive a single dose of FDL169 in both fasted and fed states
Part 2:
Part 2 of the study is a randomised, double-blind, placebo-controlled, dose-escalation study to assess the safety, tolerability and PK profiles following multiple oral administrations of FDL169 to healthy male subjects. Forty-eight male subjects, in cohorts of twelve, will be included in Part 2 of the study. It is planned to test up to four dose levels of FDL169 in Part 2.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo single dose | Placebo Comparator | Placebo administered as a single dose |
|
| Single dose (Dose level 1) | Experimental | FDL169 (Dose level 1) administered as a single dose |
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| Single dose (Dose level 2) | Experimental | FDL169 (Dose level 2) administered as a single dose |
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| Single dose (Dose level 3) | Experimental | FDL169 (Dose level 3) administered as a single dose |
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| Single dose (Dose level 4) | Experimental | FDL169 (Dose level 4) administered as a single dose |
|
| Single dose (Dose level 5) | Experimental | FDL169 (Dose level 5) administered as a single dose |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FDL169 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part 1A: safety and tolerability for 48 h following single oral doses of FDL169 (Vital signs, electrocardiogram (ECG), safety laboratory data and adverse events (AEs) | Vital signs, electrocardiogram (ECG), safety laboratory data and adverse events (AEs) | Multiple points from screening to follow-up (up to 28 days) |
| Part 1B: food effect on the tolerability of FDL169 for 48 h following a single dose | Vital signs, ECG, safety laboratory data and AEs | Multiple points from screening to follow-up (up to 42 days) |
| Part 2: safety and tolerability following multiple oral doses of FDL169 (assessed throughout dosing and for 24 h post-final dose) (Vital signs, ECG, safety laboratory data and AEs) | Vital signs, ECG, safety laboratory data and AEs | Multiple points from screening to follow-up (up to 42 days) |
| Part 1B: food effect on the pharmacokinetics of FDL169 for 48 h following a single dose | Pharmacokinetic parameters: Cmax, tmax, lambdaz, t1/2, AUC(0-t), AUC(0-tau), AUC (0-inf) CL/F and AUC%extrapolated | Multiple points from pre-dose to 48 h post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: pharmacokinetic profile for 48 h following single oral doses of FDL169 | Pharmacokinetic parameters: Cmax, tmax, lambdaz, t1/2, AUC(0-t), AUC(0-tau), AUC (0-inf) CL/F and AUC%extrapolated | Multiple points from pre-dose to 48 h post-dose |
| Part 2: pharmacokinetic profile following multiple oral doses of FDL169 (assessed throughout dosing and for 24 h post-final dose) |
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Inclusion Criteria:
Healthy male subjects aged 18 to 45 years who fulfil standard safety screening assessments for the study (haematology/biochemistry, urinalysis, 12-lead electrocardiogram (ECG), vital signs and oral temperature) and who in the opinion of the Investigator, are medically suitable to participate in the study. Male subjects and their partners must be willing to use an effective method of contraception from first dose of investigational medicinal product (IMP) and for 3 months after the last dose of IMP.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Salvatore Febbraro, MD | Simbec Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Simbec Research Ltd | Merthyr Tydfil | Wales | CF48 4DR | 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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| Single dose (Dose level 6) | Experimental | FDL169 (Dose level 6) administered as a single dose |
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| Single dose (Dose level 7) | Experimental | FDL169 (Dose level 7) administered as a single dose |
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| Single dose (Dose level 8) | Experimental | FDL169 (Dose level 8) administered as a single dose |
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| Additional single dose 1 | Experimental | Single dose of FDL169 to be administered at a dose level to be determined (up to Dose level 8) |
|
| Additional single dose 2 | Experimental | Single dose of FDL169 to be administered at a dose level to be determined (up to Dose level 8) |
|
| Additional single dose 3 | Experimental | Single dose of FDL169 to be administered at a dose level to be determined (up to Dose level 8) |
|
| Additional single dose 4 | Experimental | Single dose of FDL169 to be administered at a dose level to be determined (up to Dose level 8) |
|
| Food effect - fasted | Experimental | Single dose of FDL169 in fasted conditions |
|
| Food effect - fed | Experimental | Single dose of FDL169 in fed conditions |
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| Placebo - multiple dose | Placebo Comparator | Repeat doses of placebo |
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| Multiple dose - Dose level 1 | Experimental | Repeat doses of FDL169 to be administered at a dose level to be determined (up to Dose level 8) |
|
| Multiple dose - Dose level 2 | Experimental | Repeat doses of FDL169 to be administered at a dose level to be determined (up to Dose level 8) |
|
| Multiple dose - Dose level 3 | Experimental | Repeat doses of FDL169 to be administered at a dose level to be determined (up to Dose level 8) |
|
| Multiple dose - Dose level 4 | Experimental | Repeat doses of FDL169 to be administered at a dose level to be determined (up to Dose level 8) |
|
| Multiple dose - additional dose level 1 | Experimental | Repeat doses of FDL169 to be administered at a dose level to be determined (up to Dose level 8) |
|
| Multiple dose - additional dose level 2 | Experimental | Repeat doses of FDL169 to be administered at a dose level to be determined (up to Dose level 8) |
|
| Placebo | Drug |
|
Pharmacokinetic parameters: Cmax, tmax, lambdaz, t1/2, AUC(0-t), AUC(0-tau), AUC (0-inf) CL/F and AUC%extrapolated |
| Multiple points from pre-dose to 24 h post-dosing on Day 14 |
| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |