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

• ClinicalTrials.gov Identifier: NCT03372629
• Recruitment Status: Completed
• First Posted: December 13, 2017
• Last Update Posted: December 19, 2018
• Sponsor: Idorsia Pharmaceuticals Ltd.
• Information provided by (Responsible Party): Idorsia Pharmaceuticals Ltd.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Healthy Subjects	Drug: ID-085; Drug: Placebo oral capsule	Phase 1

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 88 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Other
• 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
• Actual Study Start Date: January 12, 2018
• Actual Primary Completion Date: December 2, 2018
• Actual Study Completion Date: December 2, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Changes from baseline in PQ/PR interval (ms) [ Time Frame: 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
2. Changes from baseline in QRS interval (ms) [ Time Frame: 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
3. Changes from baseline in QT corrected for Bazett's formula (QTcB) interval (ms) [ Time Frame: 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
4. Changes from baseline in RR interval (ms) [ Time Frame: 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
5. Changes from baseline in heart rate (bpm) [ Time Frame: 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
6. Changes from baseline in supine systolic blood pressure [ Time Frame: up to 48 hours post-dose (Part A); up to Day 10 (Part B) ]
   mm Hg
7. Changes from baseline in supine diastolic blood pressure [ Time Frame: up to 48 hours post-dose (Part A); up to Day 10 (Part B) ]
   mm Hg
8. Changes from baseline in supine pulse rate [ Time Frame: up to 48 hours post-dose (Part A); up to Day 10 (Part B) ]
   bpm
9. Changes from baseline in body weight [ Time Frame: up to 48 hours post-dose (Part A); up to Day 10 (Part B) ]
   kg
10. Number of patients with treatment-emergent AEs and SAEs for each treatment period [ Time Frame: up to 48 hours post-dose (Part A); up to Day 10 (Part B) ]
    Treatment-emergent AEs and treatment-emergent serious AEs

Secondary Outcome Measures :

1. Maximum plasma concentration (Cmax) [ Time Frame: up to Day 3 (Part A), up to Day 10 (Part B) ]
2. Time to reach Cmax (tmax) [ Time Frame: up to Day 3 (Part A), up to Day 10 (Part B) ]
3. Terminal half-life [t(1/2)] [ Time Frame: up to Day 3 (Part A), up to Day 10 (Part B) ]
4. Area under the plasma concentration-time curve from zero to time t of the last measured concentration above the limit of quantification (AUC0-t) [ Time Frame: up to Day 3 (Part A), up to Day 10 (Part B) ]

Eligibility Criteria

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

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.

Contacts and Locations

Locations

United Kingdom

Covance Clinical Research Unit - Clinical Pharmacology Services

Leeds, United Kingdom, LS2 9LH

Sponsors and Collaborators

Idorsia Pharmaceuticals Ltd.

Investigators

• Study Director: Clinical Trials; Idorsia Pharmaceuticals Ltd.

More Information

• Responsible Party: Idorsia Pharmaceuticals Ltd.
• ClinicalTrials.gov Identifier: NCT03372629
• Other Study ID Numbers: ID-085-101; 2017-004124-30 ( EudraCT Number )
• First Posted: December 13, 2017
• Last Update Posted: December 19, 2018
• Last Verified: December 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No