A PHASE 1, RANDOMIZED, OPEN LABEL, 2-WAY CROSSOVER STUDY TO ESTIMATE THE EFFECT OF MULTIPLE DOSE PF-06651600 ON THE PHARMACOKINETICS OF SINGLE DOSE ORAL CONTRACEPTIVE STEROIDS IN HEALTHY FEMALE SUBJECTS
Sponsor study identifier
interventional
12
1 country
2
Study Start
September 21, 2018
Actual (reported)Primary Completion
November 23, 2018
Actual (reported)Study Completion
November 23, 2018
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 23, 2018
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 6, 2018
Actual (reported)July 31, 2018
Actual (reported)September 21, 2018
Actual (reported)November 23, 2018
Actual (reported)November 23, 2018
Actual (reported)Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for EE
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).
0 (pre-dose),1, 1.5. 2,4,6,8,12,24 and 48 hours post-dose
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for LN
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).
0 (pre-dose), 1, 1.5, 2, 4, 6, 8, 12, 24 and 48 hours post-dose
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.
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 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.
200 mg by mouth (PO) Once daily (QD) for 11 days
Single dose of Oral tablet containing 30 ug EE and 150 ug of LN
Quotient Sciences
Coral Gables, Florida, 33134, United States
Quotient Sciences-Miami, Inc.
Miami, Florida, 33126, United States
Pfizer CT.gov Call Center
Pfizer
12 participants (actual enrollment reported by the registry).
First Submitted
July 6, 2018
First Posted
July 31, 2018
Study Start
September 21, 2018
Actual (reported)Bioequivalence Study of PF-06651600 Capsules Relative to Tablets and Estimation of Food Effect on Capsules.
Bioavailability Study of PF-06651600 Formulations in Healthy Participants
Contact the study team to confirm eligibility.
Primary Completion
November 23, 2018
Actual (reported)Study Completion
November 23, 2018
Actual (reported)Last Updated
April 9, 2019
Record last verified: 2019-04
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: