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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Subjects
• Intervention / Treatment: Drug: ID-085; Drug: Placebo oral capsule

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.

• Study Type: Interventional
• Enrollment (Actual): 88
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Leeds, United Kingdom, LS2 9LH
    • Covance Clinical Research Unit - Clinical Pharmacology Services

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ID-085, single ascending dose (Part A); 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)	Drug: ID-085; Hard gelatin capsules for oral administration formulated in strengths of 10 mg, 100 mg, and 200 mg
Placebo Comparator: Placebo, single ascending dose (Part A); Matched placebo administered as single ascending doses in parallel to ID-085	Drug: Placebo oral capsule; Placebo capsules matching ID-085 capsules
Experimental: ID-085 multiple ascending dose (Part B); 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	Drug: ID-085; Hard gelatin capsules for oral administration formulated in strengths of 10 mg, 100 mg, and 200 mg
Placebo Comparator: Placebo, multiple ascending dose (Part B); Matched placebo administered as single ascending doses in parallel to ID-085	Drug: Placebo oral capsule; Placebo capsules matching ID-085 capsules

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)
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)

Secondary Outcome Measures

Outcome Measure	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)]	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)

Collaborators and Investigators

• Sponsor: Idorsia Pharmaceuticals Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): January 12, 2018
• Primary Completion (Actual): December 2, 2018
• Study Completion (Actual): December 2, 2018

Study Registration Dates

• First Submitted: December 5, 2017
• First Submitted That Met QC Criteria: December 12, 2017
• First Posted (Actual): December 13, 2017

Study Record Updates

• Last Update Posted (Actual): December 19, 2018
• Last Update Submitted That Met QC Criteria: December 18, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: ID-085-101; 2017-004124-30 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No