Trial · NCT02319148

A Study to Estimate the Effect of CYP3A4 Inhibitors (Itraconazole, Diltiazem or Verapamil) on the Pharmacokinetics of Single Dose PF- 00489791 in Healthy Volunteers

NCT02319148, Phase 1, Completed, Pfizer; results first posted 2016-09-16

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study to Estimate the Effect of CYP3A4 Inhibitors (Itraconazole, Diltiazem or Verapamil) on the Pharmacokinetics of Single Dose PF- 00489791 in Healthy Volunteers. Trials, record NCT02319148. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02319148

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Study to Estimate the Effect of CYP3A4 Inhibitors (Itraconazole, Diltiazem or Verapamil) on the Pharmacokinetics of Single Dose PF- 00489791 in Healthy Volunteers
NCT number: NCT02319148
Status: Completed
Phases: Phase 1
Enrollment: 22 participants, actual
Lead sponsor: Pfizer
Conditions: Healthy Volunteers
Interventions: itraconazole, diltiazem, SR verapamil, PF-00489791
First posted: 2014-12-18
Last updated: 2016-09-16
Other registries' IDs: eudract:2014-001979-31
Results first posted: 2016-09-16

Source ClinicalTrials.gov

Registered outcomes12

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Maximum Observed Plasma Concentration (Cmax) of PF-00489791	Pre-dose, 0.5, 1, 2, 3, 4, 6, 8 and 12 hours after PF-00489791 administration
Primary	Area Under the Plasma Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of PF-00489791	Pre-dose, 0.5, 1, 2, 3, 4, 6, 8 and 12 hours after PF-00489791 administration	AUC is a measure of the plasma concentration of the drug over time. It is used to characterize drug absorption.
Secondary	Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-00489791	Pre-dose, 0.5, 1, 2, 3, 4, 6, 8 and 12 hours after PF-00489791 administration	Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast).
Secondary	Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-00489791	Pre-dose, 0.5, 1, 2, 3, 4, 6, 8 and 12 hours after PF-00489791 administration
Secondary	Apparent Volume of Distribution (Vz/F) of PF-00489791	Pre-dose, 0.5, 1, 2, 3, 4, 6, 8 and 12 hours after PF-00489791 administration	Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.
Secondary	Apparent Oral Clearance (CL/F) of PF-00489791	Pre-dose, 0.5, 1, 2, 3, 4, 6, 8 and 12 hours after PF-00489791 administration	Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
Secondary	Terminal Elimination Half-Life (t1/2) of PF-00489791	Pre-dose, 0.5, 1, 2, 3, 4, 6, 8 and 12 hours after PF-00489791 administration	t1/2 is the time measured for the plasma concentration to decrease by one half.
Secondary	Number of Participants With Laboratory Abnormalities Meeting the Criteria for Potential Clinical Concern	Baseline up to 28 days after last study drug administration	The following laboratory parameters were analyzed: hematology (hemoglobin, hematocrit, red blood cell \[RBC\] count, RBC morphology, platelet count, white blood cell \[WBC\] count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); blood chemistry (blood urea nitrogen \[BUN\], creatinine, glucose, calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase \[AST\], alanine aminotransferase \[ALT\], total bilirubin, alkaline phosphatase, uric acid, albumin, and total protein; urinalysis (pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, microscopy \[if urine dipstick was positive for blood, protein, nitrites or leukocyte esterase\]); others (coagulation panel, circulating immune complex, and complement activation).
Secondary	Number of Participants With Potentially Clinically Significant Vital Signs Findings	Baseline up to Day 9	Vital signs assessment included pulse rate and blood pressure. Criteria for vital sign values meeting potential clinical concern included: supine/sitting pulse rate \<40 or \>120 beats per minute (bpm), standing pulse rate \<40 or \>140 bpm; systolic blood pressure (SBP) of \>=30 millimeters of mercury (mm Hg) change from baseline in same posture or SBP \<90 mm Hg, diastolic blood pressure (DBP) \>=20 mmHg change from baseline in same posture or DBP \<50 mm Hg.
Secondary	Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings	Pre-dose (Periods 1 and 2), 4, 72 and 96 hours post-dose in Period 2	ECG parameters included PR interval, QRS interval, and corrected QT interval using Fridericia's formula (QTcF). Criteria for ECG changes meeting potential clinical concern included: PR interval greater than or equal to (\>=)300 milliseconds (msec) or \>=25% increase when baseline is greater than (\>)200 msec and \>=50% increase when baseline is less than or equal to (≤)200 msec; QRS interval \>=140 msec or \>=50% increase from baseline (IFB); and QTcF \>=450 msec or \>=30 msec increase. The number of participants with potentially clinically significant ECG findings at any visit were reported.

1 to 10 of 12Source ClinicalTrials.gov

See all 12 registered outcomes

Outcomes12

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Maximum Observed Plasma Concentration (Cmax) of PF-00489791	Pre-dose, 0.5, 1, 2, 3, 4, 6, 8 and 12 hours after PF-00489791 administration	The pharmacokinetic (PK) analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.	nanograms per milliliter (ng/mL)	GEOMETRIC_MEAN
PRIMARY	Area Under the Plasma Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of PF-00489791	Pre-dose, 0.5, 1, 2, 3, 4, 6, 8 and 12 hours after PF-00489791 administration	The PK analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.	nanogramhour per milliliter (nghr/mL)	GEOMETRIC_MEAN
SECONDARY	Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-00489791	Pre-dose, 0.5, 1, 2, 3, 4, 6, 8 and 12 hours after PF-00489791 administration	The PK analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.	ng.hr/mL	GEOMETRIC_MEAN
SECONDARY	Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-00489791	Pre-dose, 0.5, 1, 2, 3, 4, 6, 8 and 12 hours after PF-00489791 administration	The PK analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.	hour	MEDIAN
SECONDARY	Apparent Volume of Distribution (Vz/F) of PF-00489791	Pre-dose, 0.5, 1, 2, 3, 4, 6, 8 and 12 hours after PF-00489791 administration	The PK analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.	liter	GEOMETRIC_MEAN
SECONDARY	Apparent Oral Clearance (CL/F) of PF-00489791	Pre-dose, 0.5, 1, 2, 3, 4, 6, 8 and 12 hours after PF-00489791 administration	The PK analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.	milliliter per minute (mL/min)	GEOMETRIC_MEAN
SECONDARY	Terminal Elimination Half-Life (t1/2) of PF-00489791	Pre-dose, 0.5, 1, 2, 3, 4, 6, 8 and 12 hours after PF-00489791 administration	The PK analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.	hour	MEAN
SECONDARY	Number of Participants With Laboratory Abnormalities Meeting the Criteria for Potential Clinical Concern	Baseline up to 28 days after last study drug administration	The safety analysis population included all participants who received the study medication.	participants	NUMBER
SECONDARY	Number of Participants With Potentially Clinically Significant Vital Signs Findings	Baseline up to Day 9	The safety analysis population included all participants who received the study medication; n=number of participants evaluated against criteria.	participants	NUMBER
SECONDARY	Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings	Pre-dose (Periods 1 and 2), 4, 72 and 96 hours post-dose in Period 2	The safety analysis population included all participants who received the study medication; n=number of participants evaluated against criteria.	participants	NUMBER

1 to 10 of 12Source ClinicalTrials.gov

See all 12 outcomes

Results by group146

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Maximum Observed Plasma Concentration (Cmax) of PF-00489791	PF-00489791 20 mg	1140	Geometric Coefficient of Variation 34	nanograms per milliliter (ng/mL)
Maximum Observed Plasma Concentration (Cmax) of PF-00489791	PF-00489791 20 mg + Itraconazole 200 mg	1238	Geometric Coefficient of Variation 33	nanograms per milliliter (ng/mL)
Maximum Observed Plasma Concentration (Cmax) of PF-00489791	PF-00489791 20 mg + Diltiazem 240 mg	1198	Geometric Coefficient of Variation 33	nanograms per milliliter (ng/mL)
Maximum Observed Plasma Concentration (Cmax) of PF-00489791	PF-00489791 20 mg + Verapamil 240 mg	1186	Geometric Coefficient of Variation 21	nanograms per milliliter (ng/mL)
Area Under the Plasma Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of PF-00489791	PF-00489791 20 mg	17880	Geometric Coefficient of Variation 36	nanogramhour per milliliter (nghr/mL)
Area Under the Plasma Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of PF-00489791	PF-00489791 20 mg + Itraconazole 200 mg	18140	Geometric Coefficient of Variation 24	nanogramhour per milliliter (nghr/mL)
Area Under the Plasma Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of PF-00489791	PF-00489791 20 mg + Diltiazem 240 mg	16840	Geometric Coefficient of Variation 20	nanogramhour per milliliter (nghr/mL)
Area Under the Plasma Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of PF-00489791	PF-00489791 20 mg + Verapamil 240 mg	19560	Geometric Coefficient of Variation 30	nanogramhour per milliliter (nghr/mL)
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-00489791	PF-00489791 20 mg	17580	Geometric Coefficient of Variation 36	ng.hr/mL
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-00489791	PF-00489791 20 mg + Itraconazole 200 mg	17980	Geometric Coefficient of Variation 24	ng.hr/mL

1 to 10 of 146Source ClinicalTrials.gov

See all 146 results by group

Participant flow36

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
First Intervention Period	STARTED	PF-00489791 20 mg	22
First Intervention Period	STARTED	PF-00489791 20 mg + Itraconazole 200 mg	0
First Intervention Period	STARTED	PF-00489791 20 mg + Diltiazem 240 mg	0
First Intervention Period	STARTED	PF-00489791 20 mg + Verapamil 240 mg	0
First Intervention Period	COMPLETED	PF-00489791 20 mg	22
First Intervention Period	COMPLETED	PF-00489791 20 mg + Itraconazole 200 mg	0
First Intervention Period	COMPLETED	PF-00489791 20 mg + Diltiazem 240 mg	0
First Intervention Period	COMPLETED	PF-00489791 20 mg + Verapamil 240 mg	0
First Intervention Period	NOT COMPLETED	PF-00489791 20 mg	0
First Intervention Period	NOT COMPLETED	PF-00489791 20 mg + Itraconazole 200 mg	0

1 to 10 of 36Source ClinicalTrials.gov

See all 36 participant flow

Adverse events189

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Palpitations	Cardiac disorders	PF-00489791 20 mg	0	22
other	Palpitations	Cardiac disorders	Itraconazole 200 mg	0	7
other	Palpitations	Cardiac disorders	Diltiazem 240 mg	1	7
other	Palpitations	Cardiac disorders	Verapamil 240 mg	0	8
other	Palpitations	Cardiac disorders	PF-00489791 20 mg + Itraconazole 200 mg	0	6
other	Palpitations	Cardiac disorders	PF-00489791 20 mg + Diltiazem 240 mg	0	6
other	Palpitations	Cardiac disorders	PF-00489791 20 mg + Verapamil 240 mg	0	6
other	Abdominal discomfort	Gastrointestinal disorders	PF-00489791 20 mg	0	22
other	Abdominal discomfort	Gastrointestinal disorders	Itraconazole 200 mg	0	7
other	Abdominal discomfort	Gastrointestinal disorders	Diltiazem 240 mg	0	7

1 to 10 of 189Source ClinicalTrials.gov

See all 189 adverse events

Adverse event totals21

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	PF-00489791 20 mg
Total, all-cause mortality	Itraconazole 200 mg
Total, all-cause mortality	Diltiazem 240 mg
Total, all-cause mortality	Verapamil 240 mg
Total, all-cause mortality	PF-00489791 20 mg + Itraconazole 200 mg
Total, all-cause mortality	PF-00489791 20 mg + Diltiazem 240 mg
Total, all-cause mortality	PF-00489791 20 mg + Verapamil 240 mg
Total, other adverse events	PF-00489791 20 mg	18	22
Total, other adverse events	Itraconazole 200 mg	6	7
Total, other adverse events	Diltiazem 240 mg	4	7

1 to 10 of 21Source ClinicalTrials.gov

See all 21 adverse event totals

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02319148

GET https://conductscience.org/api/trials/v1/NCT02319148/results?page=2

API reference For AI assistants