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NCT07784894
A Study to Investigate the Repeat-dose Pharmacokinetics of a Combined Oral Contraceptive When Given Alone and in Combination With Ganfeborole in Female Participants of Non-childbearing Potential
Conditions: Tuberculosis
Sex: Female
Ages: 18 Years – 64 Years
Healthy volunteers: Yes
Phase: PHASE1
Enrollment: 28
Sponsor: GlaxoSmithKline
Summary
This study is designed to assess the pharmacokinetics (PK), safety, and tolerability of Ganfeborole and Microgynon, an oral contraceptive containing ethinylestradiol (EE) and levonorgestrel (LNG), when Microgynon is administered alone and in combination with Ganfeborole in healthy female participants of non-childbearing potential.
Eligibility Criteria
Inclusion Criteria:
1. Participant is 18 to \=75 mL/min.
4. Normal echocardiogram or echocardiogram with normal left ventricular function with at most trace to mild valvular regurgitation is allowed and no valvular stenosis.
5. Body weight \>=40.0 kg (99 pounds \[lbs\]) and body mass index within the range 18.5 up to 30.0 kg/m\^2 (inclusive).
6. Participant of Non-childbearing Potential. Participants in the following categories are considered female PONCBP: Postmenopausal female.
A postmenopausal state is defined as no menses for 12 months without an alternative medical cause.
* A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a postmenopausal state in individuals not using hormonal contraception or hormonal replacement therapy (HRT). However, in the absence of 12 months of amenorrhea, confirmation with more than one FSH measurement is required, within the Screening period.
* Females on HRT and whose menopausal status is in doubt must discontinue HRT at least 30 days prior to the start of Treatment Period 1 to allow confirmation of postmenopausal status before study enrollment.
7. Participant is capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the Informed Consent Form (ICF) and in the protocol.
8. Additional inclusion criteria:
* Two FSH tests
* Negative pregnancy test
Exclusion Criteria:
1. History of known cardiac valve abnormalities
2. Medical history of fatty liver disease
3. Major health conditions (including ovarian, endometrial, cervical, and breast tumours as per the Microgynon label)
4. History of ovarian, endometrial, cervical and breast cancer
5. History of deep vein thrombosis (DVT)
6. Presence of hepatitis B surface antigen at Screening or within 3 months prior to starting study treatment.
7. Positive hepatitis C antibody test result at Screening or within 3 months prior to starting study treatment AND positive on reflex to hepatitis C RNA.
8. Positive HIV-1 and/or -2 antigen/antibody immunoassay at Screening.
9. Alanine aminotransferase (ALT) \>1.5×ULN. A single repeat of ALT is allowed within a single screening period to determine eligibility.
10. Bilirubin \>1.5×ULN (isolated bilirubin \>1.5×ULN is acceptable if bilirubin was fractionated and direct bilirubin \1.5xULN if direct bilirubin is \
Source: ClinicalTrials.gov (NCT07784894). StuddyBuddy aggregates publicly available trial information.