Bioavailability Study Of PF-06651600 In Healthy Subjects
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ClinicalTrials.gov Identifier: NCT02684760 |
Recruitment Status :
Completed
First Posted : February 18, 2016
Last Update Posted : June 16, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Healthy | Drug: PF-06651600 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 14 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Basic Science |
Official Title: | A Phase 1, Open Label, Single-dose 3-way Crossover Study To Evaluate The Relative Bioavailability Of A Solid Dose Formulation Of Pf-06651600 Under Fasting Conditions And The Effect Of A High Fat Meal On The Bioavailability Of The Solid Dosage Formulation Of Pf-06651600 In Healthy Subjects |
Study Start Date : | February 2016 |
Actual Primary Completion Date : | May 2016 |
Actual Study Completion Date : | May 2016 |
Arm | Intervention/treatment |
---|---|
Experimental: Cohort 1: PF-06651600
Single dose of PF-06651600 50 mg tablet (under fasted condition and following high fat meal) and 50 mg oral formulation (under fasted condition) to evaluate bioavailability.
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Drug: PF-06651600
PF-06651600 will be administered as a tablet and extemporaneously prepared solution in each cohort. |
Experimental: Cohort 2: PF-06651600
Single dose of PF-06651600 50 mg tablet (under fasted condition and following high fat meal) and 50 mg oral formulation (under fasted condition) to evaluate bioavailability.
|
Drug: PF-06651600
PF-06651600 will be administered as a tablet and extemporaneously prepared solution in each cohort. |
Experimental: Cohort 3: PF-06651600
Single dose of PF-06651600 50 mg tablet (under fasted condition and following high fat meal) and 50 mg oral formulation (under fasted condition) to evaluate bioavailability.
|
Drug: PF-06651600
PF-06651600 will be administered as a tablet and extemporaneously prepared solution in each cohort. |
Experimental: Cohort 4: PF-06651600
Single dose of PF-06651600 50 mg tablet (under fasted condition and following high fat meal) and 50 mg oral formulation (under fasted condition) to evaluate bioavailability.
|
Drug: PF-06651600
PF-06651600 will be administered as a tablet and extemporaneously prepared solution in each cohort. |
Experimental: Cohort 5: PF-06651600
Single dose of PF-06651600 50 mg tablet (under fasted condition and following high fat meal) and 50 mg oral formulation (under fasted condition) to evaluate bioavailability.
|
Drug: PF-06651600
PF-06651600 will be administered as a tablet and extemporaneously prepared solution in each cohort. |
Experimental: Cohort 6: PF-06651600
Single dose of PF-06651600 50 mg tablet (under fasted condition and following high fat meal) and 50 mg oral formulation (under fasted condition) to evaluate bioavailability.
|
Drug: PF-06651600
PF-06651600 will be administered as a tablet and extemporaneously prepared solution in each cohort. |
- Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for PF-06651600 [ Time Frame: 0, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose ]Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf)
- Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06651600 [ Time Frame: 0, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose ]Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
- Time to Reach Maximum Observed Plasma Concentration (Cmax) for PF-06651600 [ Time Frame: 0, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose ]Time to Reach Maximum Observed Plasma Concentration (Cmax)
- Plasma Decay Half Life (t1/2) for PF-06651600 [ Time Frame: 0, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose ]Plasma Decay Half-Life (t1/2)
- Time to Reach Maximum Concentration (Tmax) for PF-06651600 [ Time Frame: 0, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose ]Time to Reach Maximum Concentration (Tmax)

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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/female subjects between 18 and 55 years old, inclusive. Females must be of non-child bearing potential.
- BMI of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
- Prior history of chicken pox.
- Evidence of personally signed and dated informed consent document.
- Willing and able to comply with scheduled visits, treatment plan, lab tests and other study procedures.
Exclusion Criteria:
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, GI, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.
- History of regular alcohol consumption exceeding 14 drinks/week for females or 21 drinks/week for males.
- Screening blood pressure >140/90 mm Hg.
- Screening laboratory abnormalities as defined by the protocol.
- Unwilling or unable to comply with the Lifestyle Guidelines as defined by the protocol.

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): NCT02684760
Belgium | |
Pfizer Clinical Research Unit | |
Brussels, Belgium, 1070 |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Additional Information:
Responsible Party: | Pfizer |
ClinicalTrials.gov Identifier: | NCT02684760 History of Changes |
Other Study ID Numbers: |
B7981003 2015-004857-41 ( EudraCT Number ) |
First Posted: | February 18, 2016 Key Record Dates |
Last Update Posted: | June 16, 2016 |
Last Verified: | June 2016 |
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