A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of PF-06649751 Co-administered With Trimethobenzamide Hydrochloride in Healthy Subjects
Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: PF-06649751 (Drug); Trimethobenzamide Hydrochloride (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Pfizer Official(s) and/or principal investigator(s): Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer Constantino Kantaridis, MD, Principal Investigator, Affiliation: Pfizer
Summary
This study will test the hypothesis that PF-06649751 with continuous co-administration of
trimethobenzamide hydrochloride (TMB) with will be safe and well tolerated. Single doses of
PF-06649751 will be tested in this study, starting at a low dose and escalating to a dose
projected to be under the current limits for drug concentration.
Clinical Details
Official title: A Phase 1, Double Blind, Sponsor Open, Randomized, Placebo Controlled, Single Ascending Dose Study To Investigate The Safety, Tolerability, And Pharmacokinetics Of Pf 06649751 Co-administered With Trimethobenzamide Hydrochloride In Healthy Volunteers
Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science
Primary outcome: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)Supine and standing vital sign measurements Electrocardiogram (ECG) Number of Participants With Laboratory Test Values of Potential Clinical Importance
Secondary outcome: Maximum Observed Plasma Concentration (Cmax)Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) Area Under the Curve From Time Zero to Extrapolated Infinite Time AUCinf Time to Reach Maximum Observed Plasma Concentration (Tmax) Plasma Decay Half-Life (t1/2) Apparent Oral Clearance (CL/F) Apparent Volume of Distribution (Vz/F)
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Healthy male and/or female subjects of non childbearing potential between the ages of
18 and 55 years, inclusive.
- Body Mass Index (BMI) of 17. 5 to 30. 5 kg/m2; and a total body weight >50 kg (110
lbs).
- 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, cardiovascular, hepatic, psychiatric, neurologic, 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 study medication (whichever
is longer).
- Other severe acute or chronic medical or psychiatric condition or laboratory
abnormality that may increase the risk associated with study participation or
investigational product administration or may interfere with the interpretation of
study results and, in the judgment of the investigator, would make the subject
inappropriate for entry into this study.
Locations and Contacts
Belgium Pfizer Clinical Research Unit, Brussels 1070, Belgium
Pfizer Clinical Research Unit, Brussels B-1070, Belgium
Additional Information
Starting date: November 2014
Last updated: January 13, 2015
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