DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017