A First In Human Study In Healthy People To Evaluate Safety, Toleration, Pharmacokinetics and Pharmacodynamics of Single Oral Doses Of PF-06372865
Overview[ - collapse ][ - ]
Purpose | The purpose of this study in healthy people is to evaluate safety, toleration and time course of plasma concentration of single oral doses of PF-06372865. The pharmacodynamic activity of PF-06372865 will also be assessed. The effect of food on PK and the PK of PF-06372865 administered as a tablet formulation may also be investigated. |
---|---|
Condition | Healthy |
Intervention | Drug: PF-06372865 or Placebo Drug: PF-06372865 or Placebo Drug: PF-06372865 or Placebo Drug: PF-06372865 or Placebo or Lorazepam |
Phase | Phase 1 |
Sponsor | Pfizer |
Responsible Party | Pfizer |
ClinicalTrials.gov Identifier | NCT01951144 |
First Received | September 13, 2013 |
Last Updated | April 24, 2014 |
Last verified | April 2014 |
Tracking Information[ + expand ][ + ]
First Received Date | September 13, 2013 |
---|---|
Last Updated Date | April 24, 2014 |
Start Date | October 2013 |
Estimated Primary Completion Date | July 2014 |
Current Primary Outcome Measures |
|
Current Secondary Outcome Measures | Not Provided |
Descriptive Information[ + expand ][ + ]
Brief Title | A First In Human Study In Healthy People To Evaluate Safety, Toleration, Pharmacokinetics and Pharmacodynamics of Single Oral Doses Of PF-06372865 |
---|---|
Official Title | A Double Blind (3rd Party Open) Randomized, Placebo Controlled, Crossover Dose Escalation Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PF-06372865 in Healthy Male and Female Subjects |
Brief Summary | The purpose of this study in healthy people is to evaluate safety, toleration and time course of plasma concentration of single oral doses of PF-06372865. The pharmacodynamic activity of PF-06372865 will also be assessed. The effect of food on PK and the PK of PF-06372865 administered as a tablet formulation may also be investigated. |
Detailed Description | Not Provided |
Study Type | Interventional |
Study Phase | Phase 1 |
Study Design | Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science |
Condition | Healthy |
Intervention | Drug: PF-06372865 or Placebo PF-06372865 will be administered as an extemporaneously prepared solution for all doses unless the tablet formulation need to be evaluated. Correspondingly, placebo doses will be administered as solution or tablet. Drug: PF-06372865 or Placebo PF-06372865 will be administered as an extemporaneously prepared solution for all doses unless the tablet formulation need to be evaluated. Correspondingly, placebo doses will be administered as solution or tablet. Drug: PF-06372865 or Placebo PF-06372865 will be administered as an extemporaneously prepared solution for all doses unless the tablet formulation need to be evaluated. Correspondingly, placebo doses will be administered as solution or tablet. Drug: PF-06372865 or Placebo or Lorazepam Lorazepam 2 mg dose, PF-06372865 and placebo administered as tablet formulation |
Study Arm (s) |
|
Recruitment Information[ + expand ][ + ]
Recruitment Status | Recruiting |
---|---|
Estimated Enrollment | 42 |
Estimated Completion Date | July 2014 |
Estimated Primary Completion Date | July 2014 |
Eligibility Criteria | Inclusion Criteria: - Healthy male subjects or female subjects of non-child bearing 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). - An informed consent document signed and dated by the subject - Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. 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 time of dosing). - Any condition possibly affecting drug absorption (e.g., gastrectomy). - A positive urine drug screen. |
Gender | Both |
Ages | 18 Years |
Accepts Healthy Volunteers | Accepts Healthy Volunteers |
Contacts | Contact: Pfizer CT.gov Call Center 1-800-718-1021 |
Location Countries | Netherlands |
Administrative Information[ + expand ][ + ]
NCT Number | NCT01951144 |
---|---|
Other Study ID Numbers | B7431001 |
Has Data Monitoring Committee | No |
Information Provided By | Pfizer |
Study Sponsor | Pfizer |
Collaborators | Not Provided |
Investigators | Study Director: Pfizer CT.gov Call Center Pfizer |
Verification Date | April 2014 |
Locations[ + expand ][ + ]
Pfizer Investigational Site | Leiden, CL, Netherlands, 2333 Recruiting |
---|