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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 88 (actual)
• Sponsor: Idorsia Pharmaceuticals Ltd. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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-controlled, multiple ascending dose.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	ID-085	Hard gelatin capsules for oral administration formulated in strengths of 10 mg, 100 mg, and 200 mg
DRUG	Placebo oral capsule	Placebo capsules matching ID-085 capsules

Timeline

• Start date: 2018-01-12
• Primary completion: 2018-12-02
• Completion: 2018-12-02
• First posted: 2017-12-13
• Last updated: 2018-12-19

Locations

1 site across 1 country: United Kingdom