Effect Of Multiple Dose PF-06700841 On The Pharmacokinetics Of Single Dose Oral Contraceptive Steroids

• Status: Completed
• Trial end date: 2020-11-06
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Pfizer
• Treatments: Contraceptive Agents; Contraceptives, Oral; Estradiol; Ethinyl Estradiol; Levonorgestrel; PF-06700841

Criteria

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