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

Respiratory Syncytial Virus Infections Clinical Trial

Official title:

[14C] -RV521.HCl - A Phase 1, Open-label Study of the Absorption, Metabolism, and Excretion Following a Single Oral Dose in Healthy Male Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05873764
• Other study ID #: REVC008
• Secondary ID: C5241008
• Status: Completed
• Phase: Phase 1
• Start date: May 25, 2022
• Est. completion date: July 12, 2022

Study information

• Verified date: May 2024
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: July 12, 2022
• Est. primary completion date: July 12, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Respiratory Syncytial Virus Infections

Intervention

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

Locations

Country	Name	City	State
United States	Pharmaron Clinical Pharmacology Center	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	14C associated with % of AUC of the total in plasma	Metabolite Profiling and Identification	Day 1 (time 0) to Day 29
Primary	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	Spontaneously reported adverse events (AEs) during the Treatment Period	safety and tolerability of a single oral dose of RV521 in healthy male subjects	Day -1 to Day 29
Secondary	Spontaneously reported serious AEs (SAEs) during the Treatment Period	Safety and tolerability of a single oral dose of RV521 in healthy male subjects	Day -1 to Day 29
Secondary	Use of concomitant medications	Safety and tolerability of a single oral dose of RV521 in healthy male subjects	Day -1 to Day 29
Secondary	Unscheduled assessments as needed for management of AEs	Safety and tolerability of a single oral dose of RV521 in healthy male subjects	Day -1 to Day 29
Secondary	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	Day -1 to Day 29
Secondary	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	Day -1 to Day 29
Secondary	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	Day -1 to Day 29
Secondary	Blood/Plasma AUC Ratio	AUC0-inf of total 14C in whole blood divided by the AUC0-inf of total 14C in plasma	Day 1 (time 0 to Day 29)
Secondary	Amount of 14C excreted into nostrils per sampling interval (in units of mass-equivalents/g)	Metabolite Profiling and Identification	Day 1 (time 0) to Day 29
Secondary	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	Day 1 (time 0 to Day 29)
Secondary	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	Day 1 (time 0) to Day 29
Secondary	Structural identification of major metabolites	Identification of each metabolite that accounts for =10% of circulating radiolabel	Day 1 (time 0) to Day 29

External Links

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