Clinical trial NCT05873764: A Study to Learn About Effect of Sisunatovir in Healthy Adult Male Participants
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Respiratory Syncytial Virus Infections
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2023-05-24
Enrollment: 9
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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. 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.


Eligibility 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

Primary outcomes:
measure: Tmax (Time of maximum observed concentration)
timeFrame: Day 1 (time 0) to Day 29
measure: Cmax (Maximum observed concentration)
timeFrame: Day 1 (time 0) to Day 29
measure: AUC0-inf (Area under the concentration-time curve (AUC) extrapolated to infinity)
timeFrame: Day 1 (time 0) to Day 29
measure: AUC0-last (AUC from the time of dosing to the time of the last measurable concentration)
timeFrame: Day 1 (time 0) to Day 29
measure: lambdaz (Rate constant associated with the terminal elimination phase)
timeFrame: Day 1 (time 0) to Day 29
measure: t1/2 (half-life of the terminal elimination phase)
timeFrame: Day 1 (time 0) to Day 29
measure: CL/F (Apparent clearance of the drug from plasma after oral administration)
timeFrame: Day 1 (time 0) to Day 29
measure: Vz/F (Volume of distribution associated with the terminal phase)
timeFrame: Day 1 (time 0) to Day 29
measure: CLR (renal clearance)
timeFrame: Day 1 (time 0) to Day 29
measure: Fe (fraction of administered drug excreted into urine)
timeFrame: Day 1 (time 0) to Day 29
measure: Ae0-t (cumulative amount of 14C excreted into urine from time 0 to the last sampling interval)
timeFrame: Day 1 (time 0) to Day 29
measure: 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))
timeFrame: Day 1 (time 0) to Day 29
measure: Aet (Amount of 14C excreted into urine and feces per sampling interval (in units of mass-equivalents/g))
timeFrame: Day 1 (time 0) to Day 29
measure: Fet (Fraction of 14C excreted into urine and feces per sampling interval (in units of %))
timeFrame: Day 1 (time 0) to Day 29
measure: Fe0-t (Cumulative fraction of 14C excreted into urine or feces from time 0)
timeFrame: Day 1 (time 0) to Day 29
measure: 14C associated with % of AUC of the total in plasma
timeFrame: Day 1 (time 0) to Day 29
measure: 14C associated with % of administered dose of the total in urine and feces
timeFrame: Day 1 (time 0) to Day 29
Secondary outcomes:
measure: Spontaneously reported adverse events (AEs) during the Treatment Period
timeFrame: Day -1 to Day 29
measure: Spontaneously reported serious AEs (SAEs) during the Treatment Period
timeFrame: Day -1 to Day 29
measure: Use of concomitant medications
timeFrame: Day -1 to Day 29
measure: Unscheduled assessments as needed for management of AEs
timeFrame: Day -1 to Day 29
measure: Clinically significant changes from baseline of any of the following: Vital Signs (blood pressure, heart rate [HR], respiratory rate [RR], and oral temperature)
timeFrame: Day -1 to Day 29
measure: Clinically significant changes from baseline of any of the following: 12-lead electrocardiogram (ECD) assessments
timeFrame: Day -1 to Day 29
measure: Clinically significant changes from baseline of any of the following: Physical examinations
timeFrame: Day -1 to Day 29
measure: Blood/Plasma AUC Ratio
timeFrame: Day 1 (time 0 to Day 29)
measure: Amount of 14C excreted into nostrils per sampling interval (in units of mass-equivalents/g)
timeFrame: Day 1 (time 0) to Day 29
measure: Cumulative amount of 14C excreted into nostrils, urine, and feces from time 0 to the last sampling interval (in units of mass-equivalents/g)
timeFrame: Day 1 (time 0 to Day 29)
measure: Evaluation of total radioactivity in nasal samples following a single oral administration of [ 14C]-RV521 to healthy male subjects
timeFrame: Day 1 (time 0) to Day 29
measure: Structural identification of major metabolites
timeFrame: Day 1 (time 0) to Day 29
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Pharmaron Clinical Pharmacology Center
state: Maryland
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: