A Study To Assess The Safety, Tolerability And Pharmacokinetics Of PF-06282999 Administered Orally In Healthy Adult Subjects
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ClinicalTrials.gov Identifier: NCT01626976 |
Recruitment Status
:
Completed
First Posted
: June 25, 2012
Last Update Posted
: March 13, 2013
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Healthy | Drug: PF-06282999 Drug: Placebo | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 42 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Basic Science |
Official Title: | A Phase 1, Randomized, Double Blind, Sponsor Open, Placebo Controlled, Single Dose Escalating Study To Assess The Safety, Tolerability And Pharmacokinetics Of PF-06282999 Administered Orally In Healthy Adult Subjects |
Study Start Date : | June 2012 |
Actual Primary Completion Date : | March 2013 |
Actual Study Completion Date : | March 2013 |
Arm | Intervention/treatment |
---|---|
Experimental: Cohort 1 |
Drug: PF-06282999
Solution, doses range from 20 to 200 mg, single dose
Drug: Placebo
Solution, single dose
|
Experimental: Cohort 2 |
Drug: PF-06282999
Methylcellulose suspension, doses range 125 to 500 mg, single dose
Drug: Placebo
suspension, single dose
|
Experimental: Cohort 3 |
Drug: PF-06282999
Methylcellulose or simethicone suspension, doses range 200 to 500 mg, single dose
Drug: Placebo
suspension, single dose
|
Experimental: Cohort 4 |
Drug: PF-06282999
Methylcellulose or simethicone suspension, 500 mg dose, single dose
Drug: Placebo
suspension, single dose
|
Experimental: Cohort 5 |
Drug: PF-06282999
Simethicone or methylcellulose suspension, up to 1500 mg, single dose
Drug: Placebo
suspension, single dose
|
- Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUCinf] [ Time Frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose ]
- Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) [ Time Frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose ]
- Area Under the Curve From Time Zero to 24 hour [AUC24] [ Time Frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24 hours post-dose ]
- Maximum Observed Plasma Concentration (Cmax) [ Time Frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose ]
- Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose ]
- Apparent Oral Clearance (CL/F) [ Time Frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose ]
- Plasma Decay Half-Life (t1/2) [ Time Frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose ]
- Apparent Volume of Distribution (Vz/F) [ Time Frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose ]
- Amount of Unchanged Drug Excretion in Urine from Zero to 24 hours (Ae24) [ Time Frame: 0 to 24 hours post-dose ]
- Percent of Dose Excreted in Urine as Unchanged Drug from Zero to 24 hours (Ae24%) [ Time Frame: 0 to 24 hours post-dose ]
- Renal Clearance (CLr) [ Time Frame: 0 to 24 hours post-dose ]
- Oral temperature [ Time Frame: 0, 1, 2, 4, 8, 12,16, 24, 48 hours post-dose ]

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Ages Eligible for Study: | 18 Years to 55 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).
- Women must be of non-childbearing potential.
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
Exclusion Criteria:
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including clinically significant drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
- Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication. Herbal supplements and hormone replacement therapy must be discontinued 28 days prior to the first dose of study medication. As an exception, acetaminophen/paracetamol may be used at doses of ≤1 g/day. Limited use of non-prescription medications that are not believed to affect subject safety or the overall results of the study may be permitted on a case-by-case basis following approval by the sponsor.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01626976
Belgium | |
Pfizer Investigational Site | |
Bruxelles, Belgium, B-1070 |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Additional Information:
Responsible Party: | Pfizer |
ClinicalTrials.gov Identifier: | NCT01626976 History of Changes |
Other Study ID Numbers: |
B5211001 |
First Posted: | June 25, 2012 Key Record Dates |
Last Update Posted: | March 13, 2013 |
Last Verified: | March 2013 |
Keywords provided by Pfizer:
safety tolerability pharmacokinetics oral |
single ascending dose placebo-controlled healthy subjects |