Study S002120

A PHASE 1, RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN, PLACEBO-CONTROLLED STUDY TO ASSESS THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF SINGLE ASCENDING ORAL DOSES OF PF-07081532 IN HEALTHY ADULT PARTICIPANTS

ClinicalTrials.gov record

Registration

Registration: NCT04148209
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE1
Masking: DOUBLE
Status: COMPLETED
Enrollment: 22
Start: 2019-11-05
Primary completion: 2020-03-17
Lead sponsor: Pfizer
Conditions: Healthy
Interventions: DRUG:PF-07081532; DRUG:Placebo
Results posted: FALSE
Individual participant data sharing: NO
Secondary identifiers: EUDRACT_NUMBER:2019-003012-30; NIH:2019

Registered primary outcomes

Percentage of participants with adverse events [From screening until follow-up call (28-35 days after the last dose of investigational product)]
Percentage of participants with safety laboratory test results above/below certain threshold [Days -1, 2 and 4 of each period and at follow-up visit (7-14 days after the last dose of investigational product)]
Percentage of participants with vital signs above/below certain threshold [Days 1-4 of each period and at follow-up visit (7-14 days after the last dose of investigational product)]
Percentage of participants with 12-lead electrocardiogram (ECG) results above/below certain threshold [Days 1-4 of each period and at follow-up visit (7-14 days after the last dose of investigational product)]

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