A Trial to Evaluate the Effect of Itraconazole (ITZ), a CYP3A4 Inhibitor, on the Pharmacokinetics of Praliciguat (IW-1973) in Healthy Volunteers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-12

Study Completion Date

2018-07-06

Brief Summary

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The primary objective of the study is to evaluate the effect of itraconazole (a potent cytochrome P450 isoenzyme \[CYP\]3A inhibitor) on the pharmacokinetics of IW-1973.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Healthy Volunteers

Period 1: Single dose of IW-1973. Period 2: ITZ is dosed once daily (QD) for 17 days; a single dose of IW-1973 is administered 1 hour after the fourth ITZ QD dose.

Group Type EXPERIMENTAL

IW-1973

Intervention Type DRUG

Oral Tablet

Itraconazole

Intervention Type DRUG

Oral Capsule

Interventions

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IW-1973

Oral Tablet

Intervention Type DRUG

Itraconazole

Oral Capsule

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subject is an ambulatory adult between 18 and 75 years old at the screening visit
* Subject is in good health and has no clinically significant findings on physical examination
* Body mass index is \> 18 and \< 30.0 kg/m2 at the screening visit
* Women of reproductive potential must have a negative pregnancy test at the time of check-in and must agree to use protocol-specified contraception throughout the duration of the study and for 2 months after the final dose of study drug
* Men must agree to use protocol-specified contraception and also to not donate sperm throughout the study and for 2 months after the final dose of study drug