A STUDY TO ESTIMATE THE EFFECT OF PF-06651600 ON THE PHARMACOKINETICS (PK) OF ORAL CONTRACEPTIVE (OC)
Phase 1
Completed
- Conditions
- Healthy Females
- Interventions
- Registration Number
- NCT03608241
- Lead Sponsor
- Pfizer
- Brief Summary
This is a Phase 1, randomized, 2 way crossover, multiple dose, open label study of the effect of multiple dose PF-06651600 on single dose OC PK in healthy female subjects. Subjects will be randomized to 1 of 2 treatment sequences.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 12
Inclusion Criteria
Not provided
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Exclusion Criteria
Not provided
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Treatment sequence 1 PF-06651600 Treatment sequence 1 will receive a single dose of an oral contraceptive during the first period of the study (period 1) and then continue to the second period (Period 2) of the study where they will receive PF-06651600 every day for 11 days and a single dose of an oral contraceptive towards the end of the period. Treatment sequence 1 Ethinyl estradiol (EE) and levonogestrel (LN) Treatment sequence 1 will receive a single dose of an oral contraceptive during the first period of the study (period 1) and then continue to the second period (Period 2) of the study where they will receive PF-06651600 every day for 11 days and a single dose of an oral contraceptive towards the end of the period. Treatment Sequence 2 PF-06651600 Treatment sequence 2 will receive PF-06651600 every day for 11 days during the first period of the study (period 1) and a single dose of an oral contraceptive towards the end of this period. After completion of Period 1, there will be a washout period of at least 10 days before starting the second period of the study (period 2). During period 2, a single dose of an oral contraceptive will be received. Treatment Sequence 2 Ethinyl estradiol (EE) and levonogestrel (LN) Treatment sequence 2 will receive PF-06651600 every day for 11 days during the first period of the study (period 1) and a single dose of an oral contraceptive towards the end of this period. After completion of Period 1, there will be a washout period of at least 10 days before starting the second period of the study (period 2). During period 2, a single dose of an oral contraceptive will be received.
- Primary Outcome Measures
Name Time Method Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for LN 0 (pre-dose), 1, 1.5, 2, 4, 6, 8, 12, 24 and 48 hours post-dose AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0-t) plus AUC (t-inf).
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for EE 0 (pre-dose),1, 1.5. 2,4,6,8,12,24 and 48 hours post-dose AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0-t) plus AUC (t-inf).
- Secondary Outcome Measures
Name Time Method Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs) Baseline (Day 0) up to 28 days after last dose of study drug Number of Adverse Events by Severity Baseline up to 28 days after last dose Number of Participants With Categorical Vital Signs Data Baseline through study completion, approximately 23 days. Number of Participants With Change From Baseline in Laboratory Tests Results Baseline through study completion, approximately 23 days.
Trial Locations
- Locations (2)
Quotient Sciences-Miami, Inc.
🇺🇸Miami, Florida, United States
Quotient Sciences
🇺🇸Coral Gables, Florida, United States