Rifampicin - Respiratory Syncytial Virus Infections | Phase 1 | Pfizer, Inc. | BiopharmaWatch

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Rifampicin

Phase 1

Respiratory Syncytial Virus Infections | Small molecule | Respiratory |Pfizer, Inc.|Last Updated: Apr 22, 2024

Success Probability

Approval Probability 71%

TA Base Rate26%

Adjusted LOA41%

ML RiskLOW_RISK

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Market & Valuation

rNPV $3.2B

Market Size $9.4B

Revenue Basis $1.6B

Competitors 6

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED

Total Trials1

Total Enrollment82

FDA Designations

No designations recorded

Clinical Trials (1)

NCT ID	Title	Phase	Status	Enrollment	Velocity	Design	Start	Completion	Last Updated	Sites	Countries
NCT03782662	A Study to Learn About the Drug-drug Interactions of Sisunatovir in Healthy Adult Participants	PHASE1	COMPLETED	82	—	—	Nov 7, 2018	Mar 17, 2019	Apr 22, 2024	1	United Kingdom

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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

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)

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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

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

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Eligibility Criteria

Age Range18 Years — 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 Kingdom

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