CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 22 enrolled
Drug / intervention
itraconazole +3 moredrug
Likely dose
itraconazole 200 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02319148
NCT02319148Phase 1Completed
CompareCT.gov

A Phase 1, Randomized, Open-label, 3-sequence, 4-treatment, Incomplete Block Design To Estimate The Effect Of Steady State Cyp3a4 Inhibitors (Itraconazole, Diltiazem Or Verapamil) On The Pharmacokinetics Of Singe Dose Pf-00489791 In Healthy Volunteers

Pfizer·interventional·Posted Dec 18, 2014·Updated Sep 16, 2016

In Brief

A Phase 1 clinical trial evaluating itraconazole, diltiazem, and 2 other interventions for Healthy Volunteers. Completed, enrolled 22 participants across 1 site.

Detailed Summary

The primary objective of the study is to estimate the effects of different strong enzyme (CYP3A4) inhibitors, itraconazole, diltiazem, or verapamil on the single dose pharmacokinetics of PF-00489791 in healthy volunteers. The study will enroll approximately 18 subjects that are randomized to 1 of 3 treatment groups. The study is also intended to determine the safety and tolerability of single-dose PF- 00489791 when it is administered with steady-state itraconazole, diltiazem, or verapamil.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Volunteers
CountriesBelgium
Collaborators--

Timeline

Phase 1CompletedFinished
201520162017201820192020202120222023202420252026
First PostedDec 18, 2014
Enrollment StartJul 1, 2014
Primary CompletionOct 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 11.5 years ago

Interventions

itraconazoledrug

itraconazole dosed at 200 mg

diltiazemdrug

diltiazem dosed at 240 mg

SR verapamildrug

SR verapamil dosed at 240 mg

PF-00489791drug

PF-00489791 20 mg single dose administration