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verapamil

Phase 1

Healthy Volunteers | Small molecule | Other |Pfizer, Inc.|Last Updated: Apr 22, 2024

Target and mechanism

ModalitySmall molecule

Also known as SR verapamil

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED

Total Trials2

Total Enrollment101

FDA Designations

No designations recorded

Clinical trial landscape

verapamil · 3 trials · 2 indications

Phase 1 3

Indication

NCT03782662A Study to Learn About the Drug-drug Interactions of Sisunatovir in Healthy Adult ParticipantsRespiratory Syncytial Virus Infections

COMPLETED82 Analytics

NCT02319148A Study to Estimate the Effect of CYP3A4 Inhibitors (Itraconazole, Diltiazem or Verapamil) on the Pharmacokinetics of Single Dose PF- 00489791 in Healthy VolunteersHealthy Volunteers

COMPLETED22 Analytics

NCT00668967Bioequivalence Study Of VerapamilHealthy Volunteers

COMPLETED79 Analytics

PHASE1COMPLETED

A Study to Learn About the Drug-drug Interactions of Sisunatovir in Healthy Adult Participants

Respiratory Syncytial Virus Infections

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PHASE1COMPLETED

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

Healthy Volunteers

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PHASE1COMPLETED

Bioequivalence Study Of Verapamil

Healthy Volunteers

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Study Endpoints

Primary Endpoints

Effect of RV521 on Cmax of Midazolam

Baseline to study day 17

The specified pharmacokinetic parameter will be summarised using descriptive statistics

Effect of RV521 on tmax of Midazolam

Baseline to study day 17

The specified pharmacokinetic parameter will be summarised using descriptive statistics

Effect of RV521 on t1/2 of Midazolam

Baseline to study day 17

The specified pharmacokinetic parameter will be summarised using descriptive statistics

Effect of RV521 on AUC of Midazolam

Baseline to study day 17

The specified pharmacokinetic parameter will be summarised using descriptive statistics

Effect of RV521 on CL/F of Midazolam

Baseline to study day 17

The specified pharmacokinetic parameter will be summarised using descriptive statistics

Effect of itraconazole on Cmax of RV521

Baseline to study day 12

The specified pharmacokinetic parameter will be summarised using descriptive statistics

Effect of itraconazole on tmax of RV521

Baseline to study day 12

The specified pharmacokinetic parameter will be summarised using descriptive statistics

Effect of itraconazole on t1/2 of RV521

Baseline to study day 12

The specified pharmacokinetic parameter will be summarised using descriptive statistics

Effect of itraconazole on AUC of RV521

Baseline to study day 12

The specified pharmacokinetic parameter will be summarised using descriptive statistics

Effect of itraconazole on CL/F of RV521

Baseline to study day 12

The specified pharmacokinetic parameter will be summarised using descriptive statistics

Effect of verapamil on Cmax of RV521

Baseline to study day 16

The specified pharmacokinetic parameter will be summarised using descriptive statistics

Effect of verapamil on tmax of RV521

Baseline to study day 16

The specified pharmacokinetic parameter will be summarised using descriptive statistics

Effect of verapamil on t1/2 of RV521

Baseline to study day 16

The specified pharmacokinetic parameter will be summarised using descriptive statistics

Effect of verapamil on AUC of RV521

Baseline to study day 16

The specified pharmacokinetic parameter will be summarised using descriptive statistics

Effect of verapamil on CL/F of RV521

Baseline to study day 16

The specified pharmacokinetic parameter will be summarised using descriptive statistics

Effect of rifampicin on Cmax of RV521

Baseline to study day 15

The specified pharmacokinetic parameter will be summarised using descriptive statistics

Effect of rifampicin on tmax of RV521

Baseline to study day 15

The specified pharmacokinetic parameter will be summarised using descriptive statistics

Effect of rifampicin on t1/2 of RV521

Baseline to study day 15

The specified pharmacokinetic parameter will be summarised using descriptive statistics

Effect of rifampicin on AUC of RV521

Baseline to study day 15

The specified pharmacokinetic parameter will be summarised using descriptive statistics

Effect of rifampicin on CL/F of RV521

Baseline to study day 15

The specified pharmacokinetic parameter will be summarised using descriptive statistics

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

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.

Primary study endpoints will be AUClast, AUCinf and Cmax of R- and S-verapamil.

5 months

Secondary Endpoints

Number of subjects with treatment-related adverse events as assessed by NCI CTCAE V5.0

Screening to final study visit (performed at 7 days following the last dose of any intervention)

Number of subjects with QT/QTc interval changes relative to baseline who received RV521 (monotherapy), Midazolam (monotherapy) or RV521 and Midazolam (combination therapy)

Baseline to to final study visit (performed at 7 days following the last dose of any intervention)

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

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Study Design & Arms

AllocationRANDOMIZED

MaskingTRIPLE

ModelSEQUENTIAL

PurposeTREATMENT

Treatment Arms

Arm	Type	Description
RV521 plus Itraconazole	EXPERIMENTAL	RV521 drug substance in capsule for oral administration, a single 200 mg dose administered on D1 and a single 200 mg dose administered on D7 plus Itraconazole 100 mg capsules for oral administration, a 200 mg dose administered once daily on D4 - D10, inclusive
RV521 plus Verapamil	EXPERIMENTAL	RV521 drug substance in capsule for oral administration, a single 200 mg dose administered on D1 and a single 200 mg dose administered on D11 plus Verapamil, 80 mg tablets for oral administration, an 80 mg dose administered TDS daily on D4 - D14, inclusive
RV521 plus Rifampicin	EXPERIMENTAL	RV521 drug substance in capsule for oral administration, a single 200 mg dose administered on D1 and a single 200 mg dose administered on D10 plus Rifadin, Rifampicin, 300 mg capsules for oral administration, a 600 mg dose administered once daily on D4 - D10, inclusive
RV521 plus Midazolam	EXPERIMENTAL	RV521 drug substance in capsule for oral administration, 200 mg dose administered BID on D2 - D15, inclusive plus Buccolam 10 mg oromucosal solution of midazolam, oral syringes, a single 10 mg dose administered on D1 and a single 200 mg dose administered on D15
Placebo plus Midazolam	PLACEBO_COMPARATOR	Placebo for RV521 in capsule for oral administration, 200 mg dose administered BID on D2 - D15, inclusive plus Buccolam 10 mg oromucosal solution of midazolam, oral syringes, a single 10 mg dose administered on D1 and a single 200 mg dose administered on D15
Treatment B	EXPERIMENTAL	Treatment B subjects receive single dose administration of 20 mg PF-00489791 and multiple dose administration of itraconazole (200 mg once daily).
Treatment C	EXPERIMENTAL	Treatment C subjects receive single dose administration of 20 mg PF-00489791 and multiple dose administration of diltiazem (240 mg once daily).
Treatment D	EXPERIMENTAL	Treatment D subjects receive single dose administration of 20 mg PF-00489791 and multiple dose administration of verapamil (240 mg once daily).
Reference	OTHER	marketed extended release verapamil tablet
Test	OTHER	reformulated extended release verapamil tablet

Interventions

Name	Type	Description
Itraconazole	DRUG	Itraconazole capsules
Verapamil	DRUG	Verapamil tablets
Rifampicin	DRUG	Rifampicin capsules
Midazolam	DRUG	Midazolam oromucosal solution
Placebo for RV521	DRUG	Placebo for RV521 capsules
RV521	DRUG	RV521 capsules
diltiazem	DRUG	diltiazem dosed at 240 mg
SR verapamil	DRUG	SR verapamil dosed at 240 mg
PF-00489791	DRUG	PF-00489791 20 mg single dose administration

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Eligibility Criteria

Age Range18 Years to 45 Years

SexALL

Healthy VolunteersYes

Study Sites1

Inclusion Criteria: * Age 18 to 45 years, inclusive * Willing to comply with protocol defined contraception requirements * In good health with no history of major medical conditions * A body mass index (BMI) of 18 - 25 kg/m2 Exclusion Criteria: * Evidence of any clinically significant or currentl...

Countries:United KingdomBelgiumUnited States

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