Clinical trial NCT03372629: A Study to Evaluate if ID-085 is Safe, Its Fate in the Body as Well as Its Potential Effects on the Body in Healthy Subjects
Official title: A Two-part Single-center, Phase 1 Study to Assess the Tolerability, Safety, Pharmacokinetics (Including Food Interaction), and Pharmacodynamics of Ascending Single and Multiple Doses of ID-085 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Lead sponsor: Idorsia Pharmaceuticals Ltd.
Sponsor class: INDUSTRY
First posted: 2017-12-13
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Changes from baseline in PQ/PR interval (ms)
timeFrame: up to 48 hours post-dose (Part A); up to Day 10 (Part B)
measure: Changes from baseline in QRS interval (ms)
timeFrame: up to 48 hours post-dose (Part A); up to Day 10 (Part B)
measure: Changes from baseline in QT corrected for Bazett's formula (QTcB) interval (ms)
timeFrame: up to 48 hours post-dose (Part A); up to Day 10 (Part B)
measure: Changes from baseline in RR interval (ms)
timeFrame: up to 48 hours post-dose (Part A); up to Day 10 (Part B)
measure: Changes from baseline in heart rate (bpm)
timeFrame: up to 48 hours post-dose (Part A); up to Day 10 (Part B)
measure: Changes from baseline in supine systolic blood pressure
timeFrame: up to 48 hours post-dose (Part A); up to Day 10 (Part B)
measure: Changes from baseline in supine diastolic blood pressure
timeFrame: up to 48 hours post-dose (Part A); up to Day 10 (Part B)
measure: Changes from baseline in supine pulse rate
timeFrame: up to 48 hours post-dose (Part A); up to Day 10 (Part B)
measure: Changes from baseline in body weight
timeFrame: up to 48 hours post-dose (Part A); up to Day 10 (Part B)
measure: Number of patients with treatment-emergent AEs and SAEs for each treatment period
timeFrame: up to 48 hours post-dose (Part A); up to Day 10 (Part B)
Secondary outcomes:
measure: Maximum plasma concentration (Cmax)
timeFrame: up to Day 3 (Part A), up to Day 10 (Part B)
measure: Time to reach Cmax (tmax)
timeFrame: up to Day 3 (Part A), up to Day 10 (Part B)
measure: Terminal half-life [t(1/2)]
timeFrame: up to Day 3 (Part A), up to Day 10 (Part B)
measure: Area under the plasma concentration-time curve from zero to time t of the last measured concentration above the limit of quantification (AUC0-t)
timeFrame: up to Day 3 (Part A), up to Day 10 (Part B)
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: Covance Clinical Research Unit - Clinical Pharmacology Services
Study officials:
affiliation: Idorsia Pharmaceuticals Ltd.
name: Clinical Trials
role: STUDY_DIRECTOR
References: