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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-004124-30 | EudraCT Number |
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The objective of this study is to evaluate the tolerability, safety, and pharmacokinetic of single- and multiple-ascending doses of ID-085 in healthy subjects.
The study is designed in two parts, A and B.
Part A: single-center, double-blind, randomized, placebo-controlled, single ascending dose.
Part B: single-center, double-blind, randomized, placebo-controlled, multiple ascending dose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ID-085, single ascending dose (Part A) | Experimental | ID-085 administered at different single dose levels in a sequential manner, and in a maximum of 6 dose levels starting from 10 mg (number of cohorts and dose levels will depend on the safety and pharmacokinetic results of the previous cohort) |
|
| Placebo, single ascending dose (Part A) | Placebo Comparator | Matched placebo administered as single ascending doses in parallel to ID-085 |
|
| ID-085 multiple ascending dose (Part B) | Experimental | ID-085 administered in a twice daily (b.i.d.) dosing regimen at multiple dose levels. The starting dose will be either 10 or 30 mg and will be selected on the basis of the safety and pharmacokinetic results of the part A |
|
| Placebo, multiple ascending dose (Part B) | Placebo Comparator | Matched placebo administered as single ascending doses in parallel to ID-085 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ID-085 | Drug | Hard gelatin capsules for oral administration formulated in strengths of 10 mg, 100 mg, and 200 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes from baseline in PQ/PR interval (ms) | ECG variables are to be recorded using a standard 12-lead ECG | up to 48 hours post-dose (Part A); up to Day 10 (Part B) |
| Changes from baseline in QRS interval (ms) | ECG variables are to be recorded using a standard 12-lead ECG | up to 48 hours post-dose (Part A); up to Day 10 (Part B) |
| Changes from baseline in QT corrected for Bazett's formula (QTcB) interval (ms) | ECG variables are to be recorded using a standard 12-lead ECG | up to 48 hours post-dose (Part A); up to Day 10 (Part B) |
| Changes from baseline in RR interval (ms) | ECG variables are to be recorded using a standard 12-lead ECG | up to 48 hours post-dose (Part A); up to Day 10 (Part B) |
| Changes from baseline in heart rate (bpm) | ECG variables are to be recorded using a standard 12-lead ECG | up to 48 hours post-dose (Part A); up to Day 10 (Part B) |
| Changes from baseline in supine systolic blood pressure | mm Hg | up to 48 hours post-dose (Part A); up to Day 10 (Part B) |
| Changes from baseline in supine diastolic blood pressure | mm Hg | up to 48 hours post-dose (Part A); up to Day 10 (Part B) |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum plasma concentration (Cmax) | up to Day 3 (Part A), up to Day 10 (Part B) | |
| Time to reach Cmax (tmax) | up to Day 3 (Part A), up to Day 10 (Part B) | |
| Terminal half-life [t(1/2)] |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Idorsia Pharmaceuticals Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Covance Clinical Research Unit - Clinical Pharmacology Services | Leeds | LS2 9LH | United Kingdom |
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| Placebo oral capsule | Drug | Placebo capsules matching ID-085 capsules |
|
| Changes from baseline in supine pulse rate | bpm | up to 48 hours post-dose (Part A); up to Day 10 (Part B) |
| Changes from baseline in body weight | kg | up to 48 hours post-dose (Part A); up to Day 10 (Part B) |
| Number of patients with treatment-emergent AEs and SAEs for each treatment period | Treatment-emergent AEs and treatment-emergent serious AEs | up to 48 hours post-dose (Part A); up to Day 10 (Part B) |
| up to Day 3 (Part A), up to Day 10 (Part B) |
| Area under the plasma concentration-time curve from zero to time t of the last measured concentration above the limit of quantification (AUC0-t) | up to Day 3 (Part A), up to Day 10 (Part B) |