A Phase 1 Study To Evaluate The Pharmacokinetics And Safety Of Three Modified Release And One Immediate Release Formulations Of Tofacitinib (CP-690,550) In Healthy Volunteers
This study has been completed.
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01499004
First received: November 23, 2011
Last updated: January 11, 2012
Last verified: January 2012
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Purpose
This study will explore the drug behavior and safety following a single dose of three different 22 milligram tofacitinib (CP-690,550) modified-release formulations in 30 healthy volunteers. These formulations will be compared to 10 milligram tofacitinib (CP-690-550) in an immediate-release formulation.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Drug: tofacitinib (CP-690,550) modified-release formulation A Drug: tofacitinib (CP-690,550) modified-release formulation B1 Drug: tofacitinib (CP-690,550) modified-release formulation B2 Drug: tofacitinib (CP-690,550) immediate-release formulation |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Basic Science |
| Official Title: | A Phase 1, Randomized, Open Label, Partial Crossover Study To Evaluate The Pharmacokinetics (PK) And Safety Of Three Modified Release (MR) And One Immediate Release (IR) Formulations Of Tofacitinib (CP-690,550) In Healthy Volunteers |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- AUCinf: Area under the plasma concentration-time profile from time 0 exprapolated to infinite time [ Time Frame: 72 hours post dose ] [ Designated as safety issue: No ]
- AUClast: Area under the plasma concentration-time profile from time 0 to the last with quantifiable concentration [ Time Frame: 72 hours post dose ] [ Designated as safety issue: No ]
- Cmax: Maximum plasma concentration of tofacitinib (CP-690,550) [ Time Frame: 72 hours post dose ] [ Designated as safety issue: No ]
- Tmax: Amount of time tofacitinib (CP-690,550) is at maximum plasma concentration [ Time Frame: 72 hours post dose ] [ Designated as safety issue: No ]
- t1/2: The time required for one half of the total amount of tofacitinib (CP-690,550) to be removed from the plasma [ Time Frame: 72 hours post dose ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Frel: Relative bioavailability (Frel) of tofacitinib (CP-690,550) in the modified-release formulations compared to the immediate release formulation [ Time Frame: 24 hours post dose ] [ Designated as safety issue: No ]
| Enrollment: | 30 |
| Study Start Date: | November 2011 |
| Study Completion Date: | December 2011 |
| Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Treatment A
tofacitinib (CP-690,550) modified-release formulation A-Fed
|
Drug: tofacitinib (CP-690,550) modified-release formulation A
A single dose of 22 mg tofacitinib (CP-690,550) modified-release formulation A administered with food.
|
|
Experimental: Treatment B
tofacitinib (CP-690,550) modified-release formulation B1-Fed
|
Drug: tofacitinib (CP-690,550) modified-release formulation B1
A single dose of 22 mg tofacitinib (CP-690,550) MR-B1 formulation administered with food
|
|
Experimental: Treatment C
tofacitinib (CP-690,550) modified-release formulation A-Fasted
|
Drug: tofacitinib (CP-690,550) modified-release formulation A
A single dose of 22 mg tofacitinib (CP-690,550) modified-release formulation A administered without food
|
|
Experimental: Treatment D
tofacitinib (CP-690,550) modified-release formulation B1-Fasted
|
Drug: tofacitinib (CP-690,550) modified-release formulation B1
A single dose of 22 mg tofacitinib (CP-690,550) modified-release formulation B1 administered without food
|
|
Experimental: Treatment E
tofacitinib (CP-690,550) modified-release formulation B2-Fasted
|
Drug: tofacitinib (CP-690,550) modified-release formulation B2
A single dose of 22 mg tofacitinib (CP-690,550) modified-release formulation B2 administered without food
|
|
Experimental: Treatment F
tofacitinib (CP-690,550) immediate-release formulation-Fasted
|
Drug: tofacitinib (CP-690,550) immediate-release formulation
A single dose of 10 mg tofacitinib (CP-690,550) immediate-release formulation administered without food
|
Eligibility| Ages Eligible for Study: | 21 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Healthy male subjects and/or healthy females subjects who are of non-childbearing potential.
Exclusion Criteria:
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease;
- Clinically significant infections within the past 3 months
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT01499004 History of Changes |
| Other Study ID Numbers: | A3921131 |
| Study First Received: | November 23, 2011 |
| Last Updated: | January 11, 2012 |
| Health Authority: | Singapore: Health Sciences Authority |
Keywords provided by Pfizer:
|
tofacitinib CP-690 550 |
relative bioavailability modified release Phase 1 |
ClinicalTrials.gov processed this record on May 23, 2013