A Trial to Evaluate the Effect of Itraconazole (ITZ), a CYP3A4 Inhibitor, on the Pharmacokinetics of Praliciguat (IW-1973) in Healthy Volunteers
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
1 other identifier
interventional
24
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 healthy
Started Apr 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 9, 2018
CompletedStudy Start
First participant enrolled
April 12, 2018
CompletedFirst Posted
Study publicly available on registry
April 17, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 6, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 6, 2018
CompletedApril 3, 2019
April 1, 2019
3 months
April 9, 2018
April 1, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (7)
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
- +2 more secondary outcomes
Study Arms (1)
Healthy Volunteers
EXPERIMENTALPeriod 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Any active or unstable clinically significant medical condition
- Use of any prescribed or non-prescribed medication
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
IQVIA
Overland Park, Kansas, 66211, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 9, 2018
First Posted
April 17, 2018
Study Start
April 12, 2018
Primary Completion
July 6, 2018
Study Completion
July 6, 2018
Last Updated
April 3, 2019
Record last verified: 2019-04