Covance Clinical Research Unit - Clinical Pharmacology Services
Leeds, LS2 9LH, United Kingdom
NCT Number: NCT03372629
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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Notify Me18 year–55 year
All sexes
Interventional
Phase 1
Leeds, LS2 9LH, United Kingdom
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Hard gelatin capsules for oral administration formulated in strengths of 10 mg, 100 mg, and 200 mg
Placebo capsules matching ID-085 capsules
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
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
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
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
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
Time frame: up to 48 hours post-dose (Part A); up to Day 10 (Part B)
mm Hg
Time frame: up to 48 hours post-dose (Part A); up to Day 10 (Part B)
mm Hg
Time frame: up to 48 hours post-dose (Part A); up to Day 10 (Part B)
bpm
Time frame: up to 48 hours post-dose (Part A); up to Day 10 (Part B)
kg
Time frame: up to 48 hours post-dose (Part A); up to Day 10 (Part B)
Treatment-emergent AEs and treatment-emergent serious AEs
Time frame: up to Day 3 (Part A), up to Day 10 (Part B)
Time frame: up to Day 3 (Part A), up to Day 10 (Part B)
Time frame: up to Day 3 (Part A), up to Day 10 (Part B)
Time frame: up to Day 3 (Part A), up to Day 10 (Part B)
Idorsia Pharmaceuticals Ltd.
Industry
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
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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