Skip to main content
OpenTrials
Completed

NCT Number: NCT03782662

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

The purpose of this clinical trial is to learn about the interaction of sisunatovir with four medications (midazolam, itraconazole, rifampicin, and verapamil). These medications are known to have specific effects on enzymes and proteins that could influence drug absorption.

This study will be conducted in 4 Cohorts:

* Cohort 1 will receive midazolam and sisunatovir or placebo, * Cohort 2 will receive Itraconazole and sisunatovir, * Cohort 3 will receive verapamil and sisunatovir, * Cohort 4 will receive rifampicin and sisunatovir. A placebo looks like sisunatovir but does not contain any active medicine in it.

This study is looking for health adult participants that meet the following criteria:

1. Caucasians age 18 to 45 years 2. All fertile participants must agree to the use of highly effective contraception 3. Body mass index (BMI) of 18-25.0 kg/m2 4. Male and female participants who are overtly healthy as determined by medical evaluation. This includes medical history, physical examination, blood pressure, pulse rate, standard 12-lead ECG (electrocardiogram), and laboratory tests.

This study consists of 2 parts, Part A and Part B. Part A will enroll up to 104 participants. The design of Part B will be determined after the completion of Part A.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Respiratory Syncytial Virus Infections Infections Mononegavirales Infections Paramyxoviridae Infections Pneumovirus Infections RNA Virus Infections Virus Diseases

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Richmond Pharmacology Ltd

London, SE1 1YR, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 currently active major medical condition
  • Positive test for Hepatitis B surface antigen (HBsAg), Hepatitis C antibody (HCV Ab), or human immunodeficiency virus antibody (HIV Ab)
  • Not willing to comply with protocol defined restrictions for intake of drugs of abuse, alcohol, nicotine-containing products, medication (prescription, OTC, herbal, vitamins/minerals etc) and specified food and drink products

Treatment and study plan

Itraconazole

Drug

Itraconazole capsules

Verapamil

Drug

Verapamil tablets

rifampicin

Drug

Rifampicin capsules

Other names: Rifadin

midazolam

Drug

Midazolam oromucosal solution

Other names: Midazolam Prefilled Syringe, Buccolam

Placebo for RV521

Drug

Placebo for RV521 capsules

RV521

Drug

RV521 capsules

Primary outcomes

  1. Effect of RV521 on Cmax of Midazolam

    Time frame: Baseline to study day 17

    The specified pharmacokinetic parameter will be summarised using descriptive statistics

  2. Effect of RV521 on tmax of Midazolam

    Time frame: Baseline to study day 17

    The specified pharmacokinetic parameter will be summarised using descriptive statistics

  3. Effect of RV521 on t1/2 of Midazolam

    Time frame: Baseline to study day 17

    The specified pharmacokinetic parameter will be summarised using descriptive statistics

  4. Effect of RV521 on AUC of Midazolam

    Time frame: Baseline to study day 17

    The specified pharmacokinetic parameter will be summarised using descriptive statistics

  5. Effect of RV521 on CL/F of Midazolam

    Time frame: Baseline to study day 17

    The specified pharmacokinetic parameter will be summarised using descriptive statistics

  6. Effect of itraconazole on Cmax of RV521

    Time frame: Baseline to study day 12

    The specified pharmacokinetic parameter will be summarised using descriptive statistics

  7. Effect of itraconazole on tmax of RV521

    Time frame: Baseline to study day 12

    The specified pharmacokinetic parameter will be summarised using descriptive statistics

  8. Effect of itraconazole on t1/2 of RV521

    Time frame: Baseline to study day 12

    The specified pharmacokinetic parameter will be summarised using descriptive statistics

  9. Effect of itraconazole on AUC of RV521

    Time frame: Baseline to study day 12

    The specified pharmacokinetic parameter will be summarised using descriptive statistics

  10. Effect of itraconazole on CL/F of RV521

    Time frame: Baseline to study day 12

    The specified pharmacokinetic parameter will be summarised using descriptive statistics

  11. Effect of verapamil on Cmax of RV521

    Time frame: Baseline to study day 16

    The specified pharmacokinetic parameter will be summarised using descriptive statistics

  12. Effect of verapamil on tmax of RV521

    Time frame: Baseline to study day 16

    The specified pharmacokinetic parameter will be summarised using descriptive statistics

  13. Effect of verapamil on t1/2 of RV521

    Time frame: Baseline to study day 16

    The specified pharmacokinetic parameter will be summarised using descriptive statistics

  14. Effect of verapamil on AUC of RV521

    Time frame: Baseline to study day 16

    The specified pharmacokinetic parameter will be summarised using descriptive statistics

  15. Effect of verapamil on CL/F of RV521

    Time frame: Baseline to study day 16

    The specified pharmacokinetic parameter will be summarised using descriptive statistics

  16. Effect of rifampicin on Cmax of RV521

    Time frame: Baseline to study day 15

    The specified pharmacokinetic parameter will be summarised using descriptive statistics

  17. Effect of rifampicin on tmax of RV521

    Time frame: Baseline to study day 15

    The specified pharmacokinetic parameter will be summarised using descriptive statistics

  18. Effect of rifampicin on t1/2 of RV521

    Time frame: Baseline to study day 15

    The specified pharmacokinetic parameter will be summarised using descriptive statistics

  19. Effect of rifampicin on AUC of RV521

    Time frame: Baseline to study day 15

    The specified pharmacokinetic parameter will be summarised using descriptive statistics

  20. Effect of rifampicin on CL/F of RV521

    Time frame: Baseline to study day 15

    The specified pharmacokinetic parameter will be summarised using descriptive statistics

Secondary outcomes

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

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

    The number of subjects with treatment-related adverse events will be summarised by treatment group using descriptive statistics

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

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

    Descriptive statistics will be given by time point and dose-group for absolute values and change from baseline. Results will be tabulated and for QTc, the difference to time matched placebo will also be displayed

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

An Adaptive, Part Open-label, Part Randomised Phase 1 Clinical Trial in Healthy Volunteers to Study Drug Interactions With RV521 Including Those Mediated by CYP3A4 and P-glycoprotein

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Dec 20, 2018
Registry last updated
Apr 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.