Clinical trial NCT02262767: A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of PF-06649751 Co-administered With Trimethobenzamide Hydrochloride in Healthy Subjects
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Phase 1, Randomized, Double Blind, Placebo-Controlled, Single-Dose Escalation, Safety, Tolerability, Pharmacokinetic, PF-06649751, Trimethobenzamide
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2014-10-13
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief 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.


Eligibility 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.

Primary outcomes:
measure: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: 0 - 4 weeks
measure: Supine and standing vital sign measurements
timeFrame: 0 - 4 weeks
measure: Electrocardiogram (ECG)
timeFrame: 0 - 4 weeks
measure: Number of Participants With Laboratory Test Values of Potential Clinical Importance
timeFrame: 0 - 4 weeks
Secondary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: Day 1
measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
timeFrame: Day 1 - 5
measure: Area Under the Curve From Time Zero to Extrapolated Infinite Time AUCinf
timeFrame: Day 1 - 5
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax)
timeFrame: Day 1
measure: Plasma Decay Half-Life (t1/2)
timeFrame: Day 1 - 5
measure: Apparent Oral Clearance (CL/F)
timeFrame: Day 1 - 5
measure: Apparent Volume of Distribution (Vz/F)
timeFrame: Day 1 - 5
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Belgium Pfizer Clinical Research Unit
city: Brussels
country: Belgium
facility: Pfizer Clinical Research Unit
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
affiliation: Pfizer
name: Constantino Kantaridis, MD
role: PRINCIPAL_INVESTIGATOR
References: