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

Healthy Subjects Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03372629
• Other study ID #: ID-085-101
• Secondary ID: 2017-004124-30
• Status: Completed
• Phase: Phase 1
• Start date: January 12, 2018
• Est. completion date: December 2, 2018

Study information

• Verified date: December 2018
• Source: Idorsia Pharmaceuticals Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: December 2, 2018
• Est. primary completion date: December 2, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Drug:
• ID-085
Hard gelatin capsules for oral administration formulated in strengths of 10 mg, 100 mg, and 200 mg
• Placebo oral capsule
Placebo capsules matching ID-085 capsules

Locations

Country	Name	City	State
United Kingdom	Covance Clinical Research Unit - Clinical Pharmacology Services	Leeds

Sponsors (1)

Lead Sponsor	Collaborator
Idorsia Pharmaceuticals Ltd.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	Changes from baseline in supine systolic blood pressure	mm Hg	up to 48 hours post-dose (Part A); up to Day 10 (Part B)
Primary	Changes from baseline in supine diastolic blood pressure	mm Hg	up to 48 hours post-dose (Part A); up to Day 10 (Part B)
Primary	Changes from baseline in supine pulse rate	bpm	up to 48 hours post-dose (Part A); up to Day 10 (Part B)
Primary	Changes from baseline in body weight	kg	up to 48 hours post-dose (Part A); up to Day 10 (Part B)
Primary	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	Maximum plasma concentration (Cmax)		up to Day 3 (Part A), up to Day 10 (Part B)
Secondary	Time to reach Cmax (tmax)		up to Day 3 (Part A), up to Day 10 (Part B)
Secondary	Terminal half-life [t(1/2)]		up to Day 3 (Part A), up to Day 10 (Part B)
Secondary	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)