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

NCT03372629 | Completed Phase 1

• 2 other identifiers: ID-085-1012017-004124-30
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (10)

• 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 Outcomes (4)

• 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)

Study Arms (4)

ID-085, single ascending dose (Part A)

EXPERIMENTAL

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

Placebo, single ascending dose (Part A)

PLACEBO COMPARATOR

Matched placebo administered as single ascending doses in parallel to ID-085

Drug: Placebo oral capsule

ID-085 multiple ascending dose (Part B)

EXPERIMENTAL

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

Placebo, multiple ascending dose (Part B)

PLACEBO COMPARATOR

Matched placebo administered as single ascending doses in parallel to ID-085

Drug: Placebo oral capsule

Interventions

ID-085 DRUG

Hard gelatin capsules for oral administration formulated in strengths of 10 mg, 100 mg, and 200 mg

ID-085 multiple ascending dose (Part B); ID-085, single ascending dose (Part A)

Placebo oral capsule DRUG

Placebo capsules matching ID-085 capsules

Placebo, multiple ascending dose (Part B); Placebo, single ascending dose (Part A)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Idorsia Pharmaceuticals Ltd.: lead

Study Sites (1)

Covance Clinical Research Unit - Clinical Pharmacology Services

Leeds, LS2 9LH, United Kingdom

Location

Study Officials

• Clinical Trials

  Idorsia Pharmaceuticals Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2017
• First Posted: December 13, 2017
• Study Start: January 12, 2018
• Primary Completion: December 2, 2018
• Study Completion: December 2, 2018
• Last Updated: December 19, 2018

Record last verified: 2018-12

Locations

GB (1)