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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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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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
4,565 Previous Clinical Trials
10,906,853 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,472 Previous Clinical Trials
8,088,021 Total Patients Enrolled

Media Library

Sisunatovir (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05878522 — Phase 1
Healthy Subjects Research Study Groups: Treatment A, Treatment B, Treatment C, 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the age requirement for this medical research extend to those under 40?

"The requirements for inclusion in this experiment suggest that participants should be between 18 and 65 years old. There are 59 studies specifically designed to accommodate minors, while 382 target those over the age of retirement."

Answered by AI

What level of hazard could patients encounter when taking Treatment A?

"The safety of Treatment A has been assessed at 1, given that it is a Phase 1 trial with limited data available on both its efficacy and general security."

Answered by AI

What is the eligibility criterion for participants in this trial?

"The trial is recruiting 42 participants with robust health, who are aged between 18 and 65."

Answered by AI

How many participants have been recruited for this research endeavor?

"Affirmative. Evidence available on clinicaltrials.gov indicates that this research project, which was initially posted on May 15th 2023, is actively accepting patients to participate. The trial aims to enroll 42 individuals from a single site."

Answered by AI

Are there available slots in this clinical trial for participants?

"Affirmative. Clinicaltrials.gov displays that this medical trial is actively seeking participants and began recruiting on May 15th 2023, with the most recent update being made three days later. A total of 42 patients are required for enrolment at one centre."

Answered by AI
~22 spots leftby Apr 2025