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Completed

NCT Number: 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

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.

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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Covance Clinical Research Unit - Clinical Pharmacology Services

Leeds, LS2 9LH, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ID-085

Drug

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

Placebo oral capsule

Drug

Placebo capsules matching ID-085 capsules

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Idorsia Pharmaceuticals Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Dec 13, 2017
Registry last updated
Dec 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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