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Completed

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

ClinicalTrials.gov ID NCT03499106
Sponsor Cyclerion Therapeutics
Information provided by Cyclerion Therapeutics (Responsible Party)
Last Update Posted 2019-04-03
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Study Overview

Brief Summary
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.
Official Title
An Open-label, 2-Period, Fixed-sequence, Phase 1 Study in Healthy Volunteers to Evaluate the Effect of Itraconazole, a Potent CYP3A Inhibitor, on the Pharmacokinetics of IW-1973
Conditions
Healthy
Intervention / Treatment
  • Drug: IW-1973
  • Drug: Itraconazole
  • Drug: IW-1973
  • Drug: Itraconazole
Other Study ID Numbers
  • C1973-104
Study Start (Actual)
2018-04-12
Primary Completion (Actual)
2018-07-06
Study Completion (Actual)
2018-07-06
Enrollment (Actual)
24
Study Type
Interventional
Phase
Phase 1

Contacts and Locations

This section provides contact details for people who can answer questions about joining this study, and information on where this study is taking place.

To learn more, please see the Contacts and Locations section in How to Read a Study Record(https://clinicaltrials.gov/study-basics/how-to-read-study-record#contacts-and-locations).

This study has 1 location
United States
Kansas Locations
Overland Park, Kansas, United States, 66211

IQVIA
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Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies(https://clinicaltrials.gov/study-basics/learn-about-studies).
Eligibility Criteria
Description

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
  • Other inclusion criteria per protocol

Exclusion Criteria:

  • Any active or unstable clinically significant medical condition
  • Use of any prescribed or non-prescribed medication
  • Other exclusion criteria per protocol
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Ages Eligible for Study
18 Years to 75 Years (AdultOlder Adult )
Sexes Eligible for Study
All
Accepts Healthy Volunteers
Yes

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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Design Details
Primary Purpose : Other
Allocation : N/A
Interventional Model : Single Group Assignment
Masking : None (Open Label)

Arms and Interventions

Participant Group/Arm Intervention/Treatment
Participant Group/Arm Experimental: 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.
Intervention/Treatment Drug: IW-1973
  • Oral Tablet

Drug: Itraconazole
  • Oral Capsule

Primary Outcome Measures
Outcome Measure Measure Description Time Frame
Area Under the Plasma Concentration Time Curve of IW-1973 From Time Zero Extrapolated to Infinity (AUC[0-inf]) Predose and up to 14 days post dose of IW-1973
Maximum Observed Plasma Concentration (Cmax) of IW-1973 Predose and up to 14 days post dose of IW-1973
Secondary Outcome Measures
Outcome Measure Measure Description Time Frame
Time to Cmax (Tmax) of IW-1973 Predose and up to 14 days post dose of IW-1973
Area Under the Concentration-Time Curve From Time Zero to 24 hours AUC(0-24) Postdose of IW-1973 Predose and up to 14 days post dose of IW-1973
Area Under the Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC[0-last]) of IW-1973 Predose and up to 14 days post dose of IW-1973
Apparent Terminal Half-Life (t1/2) of IW-1973 Predose and up to 14 days post dose of IW-1973
Apparent Terminal Rate Constant (lambda[z]) of IW-1973 Predose and up to 14 days post dose of IW-1973
Apparent Total Plasma Clearance (CL/F) of IW-1973 Predose and up to 14 days post dose of IW-1973
Apparent Volume of Distribution (Vz/F) of IW-1973 Predose and up to 14 days post dose of IW-1973

Collaborators and Investigators

This is where you will find people and organizations involved with this study.
Sponsor
Cyclerion Therapeutics

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
2018-04-09
First Submitted that Met QC Criteria
2018-04-13
First Posted
2018-04-17
Study Record Updates
Last Update Submitted that met QC Criteria
2019-04-01
Last Update Posted
2019-04-03
Last Verified
2019-04

More Information

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