Healthy Subjects
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGID-085
Hard gelatin capsules for oral administration formulated in strengths of 10 mg, 100 mg, and 200 mg
DRUGPlacebo oral capsule
Placebo capsules matching ID-085 capsules
Sponsors
Idorsia Pharmaceuticals Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Signed informed consent in the local language prior to any study-mandated procedure. * Healthy male subjects for Part A, healthy male and female subjects for Part B aged between 18 and 55 years (inclusive) at screening. * No clinically significant findings on physical examination at screening. * Body mass index (BMI) of 18.0 to 30.0 kg/m2 (inclusive) at screening.
Exclusion criteria
* History or clinical evidence of any disease and/or existence of any surgical or medical condition that might interfere with the absorption, distribution, metabolism or excretion of the study treatment (appendectomy and herniotomy allowed, cholecystectomy not allowed). * Previous history of fainting, collapse, syncope, orthostatic hypotension, or vasovagal reactions. * Pregnant or lactating women. * Known allergic reactions or hypersensitivity to the study treatment or drugs of the same class, or any of the excipients. * Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with treatment-emergent AEs and SAEs for each treatment period | up to 48 hours post-dose (Part A); up to Day 10 (Part B) | Treatment-emergent AEs and treatment-emergent serious AEs |
| Changes from baseline in supine systolic blood pressure | up to 48 hours post-dose (Part A); up to Day 10 (Part B) | mm Hg |
| Changes from baseline in supine diastolic blood pressure | up to 48 hours post-dose (Part A); up to Day 10 (Part B) | mm Hg |
| Changes from baseline in supine pulse rate | up to 48 hours post-dose (Part A); up to Day 10 (Part B) | bpm |
| Changes from baseline in body weight | up to 48 hours post-dose (Part A); up to Day 10 (Part B) | kg |
| Changes from baseline in PQ/PR interval (ms) | up to 48 hours post-dose (Part A); up to Day 10 (Part B) | ECG variables are to be recorded using a standard 12-lead ECG |
| Changes from baseline in QRS interval (ms) | up to 48 hours post-dose (Part A); up to Day 10 (Part B) | ECG variables are to be recorded using a standard 12-lead ECG |
| Changes from baseline in QT corrected for Bazett's formula (QTcB) interval (ms) | up to 48 hours post-dose (Part A); up to Day 10 (Part B) | ECG variables are to be recorded using a standard 12-lead ECG |
| Changes from baseline in RR interval (ms) | up to 48 hours post-dose (Part A); up to Day 10 (Part B) | ECG variables are to be recorded using a standard 12-lead ECG |
| Changes from baseline in heart rate (bpm) | up to 48 hours post-dose (Part A); up to Day 10 (Part B) | ECG variables are to be recorded using a standard 12-lead ECG |
Secondary
| Measure | Time frame |
|---|---|
| Time to reach Cmax (tmax) | up to Day 3 (Part A), up to Day 10 (Part B) |
| Terminal half-life [t(1/2)] | 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) |
| Maximum plasma concentration (Cmax) | up to Day 3 (Part A), up to Day 10 (Part B) |
Countries
United Kingdom
Outcome results
None listed