Status:
COMPLETED
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
Lead Sponsor:
Idorsia Pharmaceuticals Ltd.
Conditions:
Healthy Subjects
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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.
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-cont...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 12 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 2 2018
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT03372629
Start Date
January 12 2018
End Date
December 2 2018
Last Update
December 19 2018
Active Locations (1)
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1
Covance Clinical Research Unit - Clinical Pharmacology Services
Leeds, United Kingdom, LS2 9LH