Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:05 PM
Ignite Modification Date:
2025-12-24 @ 5:05 PM
NCT ID:
NCT04267250
Eligibility 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
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT04267250
Study Brief:
Protocol Section:
NCT04267250