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

NCT05873764 | Completed Phase 1 FDA Drug

• 2 other identifiers: REVC008C5241008
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.Males age 18 to 55 years
2. 2.All fertile participants must agree to the use of highly effective contraception
3. 3.Body mass index (BMI) of 18 to 32.0 kg/m2; body weight of 55.0 to 100.0 kg.
4. 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.

Conditions

Respiratory Syncytial Virus Infections

Outcome Measures

Primary Outcomes (17)

• 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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  Day 1 (time 0) to Day 29

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

  Metabolite Profiling and Identification

  Day 1 (time 0) to Day 29

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

  Metabolite Profiling and Identification

  Day 1 (time 0) to Day 29

Secondary Outcomes (12)

• Spontaneously reported adverse events (AEs) during the Treatment Period

  Day -1 to Day 29

• Spontaneously reported serious AEs (SAEs) during the Treatment Period

  Day -1 to Day 29

• Use of concomitant medications

  Day -1 to Day 29

• Unscheduled assessments as needed for management of AEs

  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)

  Day -1 to Day 29

Study Arms (1)

200 mg RV521/78 µCi [ 14C]-RV521

EXPERIMENTAL

200 mg RV521/78 µCi \[ 14C\]-RV521

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

Interventions

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

200 mg RV521/78 µCi \[ 14C\]-RV521

200 mg RV521/78 µCi [ 14C]-RV521

Eligibility Criteria

• Age: 18 Years - 55 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pharmaron Clinical Pharmacology Center

Baltimore, Maryland, 21201, United States

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Respiratory Syncytial Virus Infections

Condition Hierarchy (Ancestors)

Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2023
• First Posted: May 24, 2023
• Study Start: May 25, 2022
• Primary Completion: July 12, 2022
• Study Completion: July 12, 2022
• Last Updated: May 16, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)