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

Completed · Phase 1

Conditions studied: Healthy Female Volunteers

In brief

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.

Key facts

Study ID

NCT04267250

Run by

Pfizer

People needed

18

Starts

2020-08-24

Expected to finish

2020-11-06

Last updated by the study team

2020-11-13

Who can join

Age: 18 and older, up to 60. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Quotient Sciences Screening Office — Coral Gables, Florida, United States
• Quotient Sciences-Miami — Miami, Florida, United States

Full record on ClinicalTrials.gov

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