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

Pfizer9 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Respiratory Syncytial Virus Infections

Interventions

Eligibility

Sex: MALEMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Tmax (Time of maximum observed concentration)

PK parameters of total radioactivity and RV521 following a single oral administration of \[ 14C\]-RV521 to healthy male subjects

Time frame: Day 1 (time 0) to Day 29

Cmax (Maximum observed concentration)

PK parameters of total radioactivity and RV521 following a single oral administration of \[ 14C\]-RV521 to healthy male subjects

Time frame: Day 1 (time 0) to Day 29

AUC0-inf (Area under the concentration-time curve (AUC) extrapolated to infinity)

PK parameters of total radioactivity and RV521 following a single oral administration of \[ 14C\]-RV521 to healthy male subjects

Time frame: Day 1 (time 0) to Day 29

AUC0-last (AUC from the time of dosing to the time of the last measurable concentration)

PK parameters of total radioactivity and RV521 following a single oral administration of \[ 14C\]-RV521 to healthy male subjects

Time frame: Day 1 (time 0) to Day 29

lambdaz (Rate constant associated with the terminal elimination phase)

PK parameters of total radioactivity and RV521 following a single oral administration of \[ 14C\]-RV521 to healthy male subjects

Time frame: Day 1 (time 0) to Day 29

t1/2 (half-life of the terminal elimination phase)

PK parameters of total radioactivity and RV521 following a single oral administration of \[ 14C\]-RV521 to healthy male subjects

Time frame: Day 1 (time 0) to Day 29

CL/F (Apparent clearance of the drug from plasma after oral administration)

PK parameters of total radioactivity and RV521 following a single oral administration of \[ 14C\]-RV521 to healthy male subjects

Time frame: Day 1 (time 0) to Day 29

Vz/F (Volume of distribution associated with the terminal phase)

PK parameters of total radioactivity and RV521 following a single oral administration of \[ 14C\]-RV521 to healthy male subjects

Time frame: Day 1 (time 0) to Day 29

CLR (renal clearance)

PK parameters of total radioactivity and RV521 following a single oral administration of \[ 14C\]-RV521 to healthy male subjects

Time frame: Day 1 (time 0) to Day 29

Fe (fraction of administered drug excreted into urine)

PK parameters of total radioactivity and RV521 following a single oral administration of \[ 14C\]-RV521 to healthy male subjects

Time frame: Day 1 (time 0) to Day 29

Ae0-t (cumulative amount of 14C excreted into urine from time 0 to the last sampling interval)

PK parameters of total radioactivity and RV521 following a single oral administration of \[ 14C\]-RV521 to healthy male subjects

Time frame: Day 1 (time 0) to Day 29

Ae0-t (Cumulative amount of 14C excreted into urine and feces from time 0 to the last sampling interval (in units of mass-equivalents/g))

Mass balance parameters in urinary and fecal excretion of radioactivity

Time frame: Day 1 (time 0) to Day 29

Aet (Amount of 14C excreted into urine and feces per sampling interval (in units of mass-equivalents/g))

Mass balance parameters in urinary and fecal excretion of radioactivity

Time frame: Day 1 (time 0) to Day 29

Fet (Fraction of 14C excreted into urine and feces per sampling interval (in units of %))

Mass balance parameters in urinary and fecal excretion of radioactivity

Time frame: Day 1 (time 0) to Day 29

Fe0-t (Cumulative fraction of 14C excreted into urine or feces from time 0)

Mass balance parameters in urinary and fecal excretion of radioactivity

Time frame: Day 1 (time 0) to Day 29

14C associated with % of AUC of the total in plasma

Metabolite Profiling and Identification

Time frame: Day 1 (time 0) to Day 29

14C associated with % of administered dose of the total in urine and feces

Metabolite Profiling and Identification

Time frame: Day 1 (time 0) to Day 29

Secondary Outcomes

Spontaneously reported adverse events (AEs) during the Treatment Period

safety and tolerability of a single oral dose of RV521 in healthy male subjects

Time frame: Day -1 to Day 29

Spontaneously reported serious AEs (SAEs) during the Treatment Period

Safety and tolerability of a single oral dose of RV521 in healthy male subjects

Time frame: Day -1 to Day 29

Use of concomitant medications

Safety and tolerability of a single oral dose of RV521 in healthy male subjects

Time frame: Day -1 to Day 29

Unscheduled assessments as needed for management of AEs

Safety and tolerability of a single oral dose of RV521 in healthy male subjects

Time frame: Day -1 to Day 29

Clinically significant changes from baseline of any of the following: Vital Signs (blood pressure, heart rate [HR], respiratory rate [RR], and oral temperature)

Safety and tolerability of a single oral dose of RV521 in healthy male subjects

Time frame: Day -1 to Day 29

Clinically significant changes from baseline of any of the following: 12-lead electrocardiogram (ECD) assessments

Safety and tolerability of a single oral dose of RV521 in healthy male subjects

Time frame: Day -1 to Day 29

Clinically significant changes from baseline of any of the following: Physical examinations

Safety and tolerability of a single oral dose of RV521 in healthy male subjects

Time frame: Day -1 to Day 29

Blood/Plasma AUC Ratio

AUC0-inf of total 14C in whole blood divided by the AUC0-inf of total 14C in plasma

Cumulative amount of 14C excreted into nostrils, urine, and feces from time 0 to the last sampling interval (in units of mass-equivalents/g)

Metabolite Profiling and Identification

Time frame: Day 1 (time 0 to Day 29)

Evaluation of total radioactivity in nasal samples following a single oral administration of [ 14C]-RV521 to healthy male subjects

PK parameters of total radioactivity and RV521 following a single oral administration of \[ 14C\]-RV521 to healthy male subjects

Time frame: Day 1 (time 0) to Day 29

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes