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First In Human, Single Escalating Oral Dose Study Of PF-06882961 In Healthy Adult Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03309241
Recruitment Status : Completed
First Posted : October 13, 2017
Last Update Posted : April 2, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of single oral doses of PF-06882961 in healthy adult subjects. This is the first clinical study of PF-06882961.

Condition or disease Intervention/treatment Phase
Healthy Subjects Drug: PF-06882961 Other: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: Double-blind (sponsor open)
Primary Purpose: Basic Science
Official Title: A Phase 1, Randomized, Double-blind, Placebo-controlled Study To Assess The Safety, Tolerability, And Pharmacokinetics Of Single Escalating Oral Doses Of Pf-06882961 In Healthy Adult Subjects
Actual Study Start Date : October 17, 2017
Actual Primary Completion Date : February 21, 2018
Actual Study Completion Date : March 22, 2018

Arm Intervention/treatment
Experimental: Cohort 1
Single Ascending Dose in crossover design with placebo substitution. Administration under fed or fasted conditions as tablet or solution formulation. At least 7 days washout between doses in an individual subject.
Drug: PF-06882961
Single Ascending Doses of PF-06882961 from 3mg to TBD mg.

Other: Placebo
Placebo Single Dose

Experimental: Cohort 2
Single Ascending Dose in crossover design with placebo substitution. Administration under fed or fasted conditions as tablet or solution formulation. At least 7 days washout between doses in an individual subject.
Drug: PF-06882961
Single Ascending Doses of PF-06882961 from 3mg to TBD mg.

Other: Placebo
Placebo Single Dose

Experimental: Cohort 3 (optional)
Single Ascending Dose administration under fed or fasted conditions as tablet or solution formulation. At least 7 days washout between doses in an individual subject.
Drug: PF-06882961
Single Ascending Doses of PF-06882961 from 3mg to TBD mg.

Other: Placebo
Placebo Single Dose




Primary Outcome Measures :
  1. Number of Participants With Treatment-Emergent Adverse Events (TEAEs) by Seriousness and Relationship to Treatment [ Time Frame: First dose of study drug up to 28 days after last dose of study drug ]
    Assessment by adverse event monitoring, 12 lead ECGs, cardiac telemetry, vital signs and clinical safety laboratory measurements.


Secondary Outcome Measures :
  1. Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) [ Time Frame: Pre-dose and at 0.3, 0.75, 1.25,2,3,4,6,8,10,12,24,36,48 hours following single dose administration ]
    Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)

  2. Maximum Observed Plasma Concentration (Cmax) [ Time Frame: Pre-dose and at 0.3, 0.75, 1.25,2,3,4,6,8,10,12,24,36,48 hours following single dose administration ]
    Maximum Observed Plasma Concentration (Cmax)

  3. Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: Pre-dose and at 0.3, 0.75, 1.25,2,3,4,6,8,10,12,24,36,48 hours following single dose administration ]
    Time to Reach Maximum Observed Plasma Concentration (Tmax)

  4. Plasma Decay Half-Life (t1/2) [ Time Frame: Pre-dose and at 0.3, 0.75, 1.25,2,3,4,6,8,10,12,24,36,48 hours following single dose administration ]
    Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy female subjects of nonchildbearing potential and/or male subjects who, at the time of screening, are between the ages of 18 and 55 years, inclusive
  • Body mass index (BMI) within 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb)
  • Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study

Exclusion Criteria:

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal (including pancreatitis), cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing.
  • Treatment with an investigational drug within 30 days (or as determined by the local requirement) or 5 half lives preceding the first dose of IP (whichever is longer).
  • Fertile male subjects who are unwilling or unable to use a highly effective method of contraception for the duration of the study and for at least 28 days after the last dose.
  • Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half lives (whichever is longer) prior to the first dose

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03309241


Locations
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United States, Connecticut
New Haven Clinical Research Unit
New Haven, Connecticut, United States, 06511
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT03309241    
Other Study ID Numbers: C3421001
First Posted: October 13, 2017    Key Record Dates
Last Update Posted: April 2, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/data_requests

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No