- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02262767
A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of PF-06649751 Co-administered With Trimethobenzamide Hydrochloride in Healthy Subjects
January 13, 2015 updated by: Pfizer
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
9
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Brussels, Belgium, B-1070
- Pfizer Clinical Research Unit
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Brussels, Belgium, 1070
- Belgium Pfizer Clinical Research Unit
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Single Ascending Doses Cohort 1
Single doses, given by oral solution, starting at 0.75 mg up to a possible maximum of 3.0 mg.
The subject will have been fasted for 10 hours prior to the single dose.
For each dosing period, 3 subjects will be given a placebo as a comparator while 6 are given active dose.
The subjects will be given concomitant trimethobenzamide hydrochloride for the 3 weeks that the subject is in the CRU.
For each of the three periods, subjects will be crossed-over from placebo or PF-06649751.
Each PF-06649751 dose is separated by one week.
|
Experimental Pfizer compound.
Trimethobenzamide Hydrochloride is indicated for the treatment of postoperative nausea and vomiting and for nausea associated with gastroenteritis.
Other Names:
|
Experimental: Single Ascending Doses Cohort 2
Single doses, given by oral solution, starting at 4.5 mg up to a possible maximum of 9.0 mg.
The subject will have been fasted for 10 hours prior to the single dose.
For each dosing period, 3 subjects will be given a placebo as a comparator while 6 are given active dose.
The subjects will be given concomitant trimethobenzamide hydrochloride for the 3 weeks that the subject is in the CRU.
For each of the three periods, subjects will be crossed-over from placebo or PF-06649751.
Each PF-06649751 dose is separated by one week.
|
Experimental Pfizer compound.
Trimethobenzamide Hydrochloride is indicated for the treatment of postoperative nausea and vomiting and for nausea associated with gastroenteritis.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame: 0 - 4 weeks
|
Counts of participants who have treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose.
Relatedness to PF-06649751 will be assessed by the investigator (Yes/No).
Participants with multiple occurrences of an AE within a category will be counted once within the category.
|
0 - 4 weeks
|
Supine and standing vital sign measurements
Time Frame: 0 - 4 weeks
|
Measurement of blood pressure and pulse rate.
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0 - 4 weeks
|
Electrocardiogram (ECG)
Time Frame: 0 - 4 weeks
|
Measurement of standard 12-lead ECG, single or triplicate
|
0 - 4 weeks
|
Number of Participants With Laboratory Test Values of Potential Clinical Importance
Time Frame: 0 - 4 weeks
|
Pre-defined criteria were established for each laboratory test to define the values that would be identified as of potential clinical importance.
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0 - 4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximum Observed Plasma Concentration (Cmax)
Time Frame: Day 1
|
Maximum plasma concentration
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Day 1
|
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
Time Frame: Day 1 - 5
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Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast).
|
Day 1 - 5
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Area Under the Curve From Time Zero to Extrapolated Infinite Time AUCinf
Time Frame: Day 1 - 5
|
AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time.
It is obtained from AUC (0 - t) plus AUC (t - inf).
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Day 1 - 5
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Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time Frame: Day 1
|
Day 1
|
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Plasma Decay Half-Life (t1/2)
Time Frame: Day 1 - 5
|
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
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Day 1 - 5
|
Apparent Oral Clearance (CL/F)
Time Frame: Day 1 - 5
|
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.
Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed.
Clearance was estimated from population pharmacokinetic (PK) modeling.
Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
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Day 1 - 5
|
Apparent Volume of Distribution (Vz/F)
Time Frame: Day 1 - 5
|
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.
Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.
|
Day 1 - 5
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Constantino Kantaridis, MD, Pfizer
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2014
Primary Completion (Actual)
December 1, 2014
Study Completion (Actual)
December 1, 2014
Study Registration Dates
First Submitted
October 9, 2014
First Submitted That Met QC Criteria
October 9, 2014
First Posted (Estimate)
October 13, 2014
Study Record Updates
Last Update Posted (Estimate)
January 14, 2015
Last Update Submitted That Met QC Criteria
January 13, 2015
Last Verified
January 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- B7601007
- 2014-003631-19 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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