Healthy Female Volunteers
Conditions
Brief summary
This Phase 1 study will assess the pharmacokinetic effect of multiple doses PF 06700841 (administered once a day) on a single dose of a combination oral contraceptive, in 18 healthy female participants who are not of childbearing potential.
Detailed description
This is a Phase 1, randomized, 2 way crossover, multiple-dose, open label study of the effect of multiple doses PF-06700841 on single dose combination oral contraceptive (OC) pharmacokinetics (PK) in healthy female participants aged 18-60. The study consists of a screening phase (up to 28 days prior to Day 1); two treatment periods during which participants are resident in the Clinical Research Unit (CRU) and a final follow-up telephone contact, which will be conducted after 28-35 following administration of the last dose. Participants will be randomized to 1 of 2 treatment sequences. A total of 18 healthy female participants (9 in each treatment sequence) will be enrolled in the study. Each treatment sequence will consist of 2 periods in a single fixed sequence. Participants will be screened within 28 days of the first dose of investigational product. Participants will report to the Clinical Research Unit (CRU) the day prior to Day 1 dosing in Period 1 for both treatment sequences, and will report to the CRU the day prior to Day 1 dosing in Period 2 for Treatment Sequence 2. In Treatment Sequence 1, participants will remain in the CRU for up to 21 days and 20 nights. There will be no washout period in Treatment Sequence 1. In Treatment Sequence 2, participants will remain in the CRU for up to 22 days and 20 nights. Participants in treatment sequence 2 will have an outpatient washout period of at least 10 days between Period 1 and Period 2. A single administration of OC in the form of 1 PORTIA or equivalent tablet will be administered in one of the two periods (reference treatment) and in the alternative treatment period, daily doses of 60 mg PF-06700841 will be administered for 13 days with a single dose of OC being administered on Day 10. PK (AUCinf, Cmax, AUClast, Tmax and t½) of OC will then be assessed at pre OC dose and over 96 hours, post OC dosing. Safety assessments will be conducted at the CRU.
Interventions
DRUGPF-06700841
60 mg by mouth (PO) once daily (QD).
Oral tablet containing 30 mcg EE and 150 mcg LN.
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy females aged 18-60 * Not of childbearing potential * Body mass index of 17.5-30.5 kg/m2 * Body weight \> 50 kg * Capable of giving signed informed consent
Exclusion criteria
* Evidence or history of clinically significant disease including irritable bowel disease; HIV; Hep B and Hep C; acute or chronic infection history; lymphoproliferative disorder; tuberculosis; hearing loss; sensitivity to heparin or heparin-induced thrombocytopenia * Any condition affecting drug absorption * Participants who have experienced major trauma or surgery in the 3 months prior to baseline * Participants in imminent need for surgery * Use of prescription or non-prescription drugs within 7 days or 5 half-lives prior to dosing * Previous administration with an investigational drug within 30 days or 5 half-lives prior to dosing * A positive urine drug test * Hypertension * ECG anomalies * Significant laboratory anomalies * History of drug abuse with less than 6 months of abstinence prior to the baseline visit * History of alcohol abuse within 6 months of screening * History of nicotine use within 30 days of baseline visit * Any contraindications to OC * History of discontinued use of OC for medical reasons * Febrile illness within 5 days prior to dosing * Vaccination with live or attenuated virus or live viral components within 6 weeks prior to dosing * History of major organ transplant * History of severe allergic or anaphylactic reaction to kinase inhibitors * have donated blood of 500mL or more within 60 days prior to dosing
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for EE | 0 (pre-dose), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post OC dose in periods 1 and 2 | 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 LN | 0 (pre-dose), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post OC dose in periods 1 and 2 | 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). |
Countries
United States
Outcome results
None listed