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Virus Therapy

Treatment A for Healthy Subjects

Phase 1
Waitlist Available
Research Sponsored by Pfizer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up on day 3, zero hour (prior to zero hour treatment administration), and at 0.25, 0.5, 1, 2, 3, 6, 12 and 24 hours post-dose
Awards & highlights

Study Summary

This trial seeks to study the effects of multiple oral doses of sisunatovir on QTc Interval in healthy participants by having them take different doses of sisunatovir and placebo over 4 days.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~on day 3, zero hour (prior to zero hour treatment administration), and at 0.25, 0.5, 1, 2, 3, 6, 12 and 24 hours post-dose
This trial's timeline: 3 weeks for screening, Varies for treatment, and on day 3, zero hour (prior to zero hour treatment administration), and at 0.25, 0.5, 1, 2, 3, 6, 12 and 24 hours post-dose for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Evaluate sisunatovir's effect on the QTc interval (msec) by assessing concentration-QT (C-QT) relationship using exposure-response modeling
Secondary outcome measures
Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities
Number of Participants With Clinically Significant Change From Baseline in Vital Signs
Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)
+1 more

Side effects data

From 2012 Phase 1 trial • 328 Patients • NCT01999114
53%
Infrequent bowel movements
45%
Nausea
42%
Headache
27%
Dizziness
24%
Vomiting
18%
Application site pruritus
15%
Application site irritation
14%
Abdominal discomfort
12%
Decreased appetite
11%
Somnolence
9%
Application site erythema
9%
Application site papules
8%
Fatigue
8%
Haematochezia
8%
Feeling hot
8%
Pruritus
8%
Hiccups
6%
Feeling drunk
6%
Diarrhoea
6%
Application site pustules
6%
Oropharyngeal pain
6%
Abdominal pain
6%
Dysuria
5%
Application site pain
3%
Flatulence
3%
Application site rash
100%
80%
60%
40%
20%
0%
Study treatment Arm
BTDS
BTDS With Naltrexone
Naltrexone
Moxifloxacin
Placebo

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Treatment DExperimental Treatment1 Intervention
7 capsules of sisunatovir administered Q12 hours for 5 doses
Group II: Treatment AExperimental Treatment1 Intervention
6 capsules of sisunatovir administered Q12 hours for 5 doses
Group III: Treatment CActive Control1 Intervention
6 capsules of placebo administered Q12 hours for 4 doses, followed by a single tablet of moxifloxacin
Group IV: Treatment BPlacebo Group1 Intervention
6 capsules of placebo administered Q12 hours for 5 doses
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
sisunatovir
2023
Completed Phase 1
~80

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

PfizerLead Sponsor
4,580 Previous Clinical Trials
14,634,160 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,485 Previous Clinical Trials
11,811,035 Total Patients Enrolled

Media Library

Sisunatovir (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05878522 — Phase 1
Healthy Subjects Research Study Groups: Treatment C, Treatment A, Treatment B, Treatment D
Healthy Subjects Clinical Trial 2023: Sisunatovir Highlights & Side Effects. Trial Name: NCT05878522 — Phase 1
Sisunatovir (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05878522 — Phase 1
~21 spots leftby May 2025
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