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Rifampicin

Phase 1

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

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment82

FDA Designations

No designations recorded

Clinical trial landscape

Rifampicin · 1 trial · 1 indication

Phase 1 1
NCT03782662A Study to Learn About the Drug-drug Interactions of Sisunatovir in Healthy Adult ParticipantsRespiratory Syncytial Virus Infections
COMPLETED82 Analytics
PHASE1COMPLETED
A Study to Learn About the Drug-drug Interactions of Sisunatovir in Healthy Adult Participants
Respiratory Syncytial Virus InfectionsUnlock trial analytics

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

ArmTypeDescription
RV521 plus ItraconazoleEXPERIMENTALRV521 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 VerapamilEXPERIMENTALRV521 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 RifampicinEXPERIMENTALRV521 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 MidazolamEXPERIMENTALRV521 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 MidazolamPLACEBO_COMPARATORPlacebo 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

NameTypeDescription
ItraconazoleDRUGItraconazole capsules
VerapamilDRUGVerapamil tablets
RifampicinDRUGRifampicin capsules
MidazolamDRUGMidazolam oromucosal solution
Placebo for RV521DRUGPlacebo for RV521 capsules
RV521DRUGRV521 capsules
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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 Kingdom
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Frequently asked questions about Rifampicin

What is Rifampicin used for in Respiratory Syncytial Virus Infections?

Rifampicin is a small molecule being investigated for use in Respiratory Syncytial Virus Infections. It is currently in Phase 1 clinical development. The drug is being studied in healthy adult participants to assess drug-drug interactions, as part of a completed trial in the United Kingdom.

What does Rifampicin target?

Rifampicin does not have a specified molecular target or target class in the available data. Therefore, its mechanism of action is not described here. The drug is being studied for its potential effects in Respiratory Syncytial Virus Infections, though the specific biological pathway it acts on has not been disclosed.

Who makes Rifampicin?

Rifampicin is being developed by Pfizer, Inc., which is publicly traded under the ticker symbol PFE. The company is conducting clinical research on this drug for Respiratory Syncytial Virus Infections, with the drug currently in Phase 1 development.

What phase is Rifampicin in?

Rifampicin is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug is being studied for Respiratory Syncytial Virus Infections, with one completed Phase 1 trial involving 82 participants.

What clinical trials is Rifampicin in?

Rifampicin has one completed clinical trial, identified as NCT03782662, titled "A Study to Learn About the Drug-drug Interactions of Sisunatovir in Healthy Adult Participants." This Phase 1 trial enrolled 82 healthy adult participants in the United Kingdom and was placebo-controlled, randomized, and double-blind.

Is Rifampicin the same as Sisunatovir?

Rifampicin is not the same as Sisunatovir. The clinical trial NCT03782662, which studies drug-drug interactions, involves both drugs, but Rifampicin is a separate investigational drug. The trial is designed to assess how these drugs interact when used together in healthy participants.