A Study to Learn About Effect of Sisunatovir in Healthy Adult Male Participants

Pfizer

Status and phase: Completed; Phase 1

Conditions: Respiratory Syncytial Virus Infections

Treatments: Drug: 200 mg RV521/78 µCi [ 14C]-RV521.

Study type: Interventional

Funder types: Industry

Identifiers

NCT05873764

REVC008

C5241008 (Other Identifier)

Details and patient eligibility

About

The purpose of this clinical trial is to learn about the safety, effects, and tolerability of the study medicine (sisunatovir).

This study is looking for healthy adult participants who meet the following criteria:

1. Males age 18 to 55 years
2. All fertile participants must agree to the use of highly effective contraception
3. Body mass index (BMI) of 18 to 32.0 kg/m2; body weight of 55.0 to 100.0 kg.
4. 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 will enroll up to 10 participants. All study participants will receive 1 dose of sisunatovir by mouth. The study duration is expected to be about 9 weeks. This includes a 28-day screening period, 16-day inpatient stay, and 2 overnight follow-up visits, if needed.

Enrollment: 9 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria (key):

• Males
• Age 18- 55 years
• Body mass index (BMI) 18.0 kg/m2 to 32.0 kg/m2
• Body weight 55.0 kg to 100.0 kg
• Considered to be in good health
• Nonsmoker
• Content of 14C in urine, whole blood, and/or plasma samples does not exceed the general environmental background level of 14C

Exclusion Criteria (key):

• Clinically significant abnormal medical history or any abnormal finding on physical examination, vital signs, ECG, laboratory tests
• History of cancer that has not been in full remission for >5 years
• Acute illness within 14 days prior to Day 1
• History of significant drug allergies
• History or presence of alcohol or drug abuse
• Recent history of incomplete bladder emptying with voiding or awakening more than once at night to void
• Usual habit of <1 or >3 bowel movements per day
• Exposure to radiation for therapeutic, diagnostic, or occupational reasons within the 12 months prior to Day 1.
• Participation in another clinical study in which a [14C]-labeled drug was administered within 1 year prior to Check-in
• Administration of another investigational medication within 60 days (or 5 half-lives, whichever is longer) prior to Day 1
• Participation in an investigational-device study within 60 days prior to Day 1
• Any ECG abnormality considered to be clinically significant by the Investigator
• QTcF interval >450 msec and QRS interval >120 msec
• Family history of long QT syndrome or of unexplained sudden death in a first-degree relative under 50 years of age
• Documented congenital or acquired long QT syndrome
• Presence of clinically significant hypertension
• Presence of clinically significant hypotension
• Loss or donation of more than 500 mL blood within 60 days prior to the Screening
• Excessive consumption of alcohol
• Use of any live vaccinations within 30 days
• Use/consumption of food or drugs known to be moderate or strong cytochrome P450 3A4 (CYP3A4) inducers or potent CYP3A4 inhibitors within 14 days or 5 half-lives, whichever is longer, prior to RV521 administration

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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9 participants in 1 patient group

200 mg RV521/78 µCi [ 14C]-RV521

Experimental group

Description:

200 mg RV521/78 µCi \[ 14C\]-RV521

Treatment:

Drug: 200 mg RV521/78 µCi [ 14C]-RV521.