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

NCT07784894 | Not Yet Recruiting Phase 1

• 2 other identifiers: 3082452026-525790-39
• Study Type: interventional
• Target: 28
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Tuberculosis

Keywords

Ganfeborole; GSK3036656; Microgynon; Ethinylestradiol and Levonorgestrel; Drug-drug interaction (DDI); Non-childbearing potential; Tuberculosis (TB)

Outcome Measures

Primary Outcomes (4)

• Area under the plasma concentration-time curve (AUC(0-tau)) over 24 hours of EE and LNG, after repeat dose, alone and in the presence of Ganfeborole on Day 10

  On Day 10 at 30 minutes pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose

• AUC(0-tau) over 24 hours of EE and LNG, after repeat dose, alone and in the presence of Ganfeborole on Day 24

  On Day 24 at 30 minutes pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose

• Maximum observed concentration (Cmax) of EE and LNG, after repeat dose, alone and in the presence of Ganfeborole on Day 10

  On Day 10, at 30 minutes pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose

• Cmax of EE and LNG, after repeat dose, alone and in the presence of Ganfeborole on Day 24

  On Day 24, at 30 minutes pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose

Secondary Outcomes (15)

• AUC(0-tau) over 24 hours of Ganfeborole in the presence of EE and LNG

  On Day 24, at 30 minutes pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose

• Cmax of Ganfeborole in the presence of EE and LNG

  On Days 16, 22 and 23, at 30 minutes pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose for each day, and on Days 24 and 25, at 30 minutes pre-dose and 24 hours post-dose for each day

• Time of maximum observed concentration (Tmax) of Ganfeborole in the presence of EE and LNG

  On Days 16, 22 and 23, at 30 minutes pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose for each day, and on Days 24 and 25, at 30 minutes pre-dose and at 24 hours post-dose for each day

• Plasma concentration over 24 hours (Ctau) of Ganfeborole in the presence of EE and LNG

  On Days 16, 22 and 23, at 30 minutes pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose for each day, and on Days 24 and 25, at 30 minutes pre-dose and 24 hours post-dose for each day

• Tmax of EE and LNG alone and in the presence of Ganfeborole

  On Days 8, 9, 22 and 23, at 30 minutes pre-dose and 24 hours post-dose for each day, and on Days 10, 24 and 25 at 30 minutes pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose for each day

Study Arms (1)

Microgynon / Ganfeborole + Microgynon Group

EXPERIMENTAL

Participants receive in Treatment Period 1: Microgynon repeat dosing from Day 1 to Day 10, and in Treatment Period 2: Ganfeborole low dose alone on Day 11, and Ganfeborole high dose once daily (OD) from Day 12 to Day 24 combined with Microgynon repeat dosing (OD) from Day 15 to Day 24.

Drug: Ganfeborole; Drug: Microgynon

Interventions

Ganfeborole DRUG

Participants receive Ganfeborole orally.

Also known as: GSK3036656

Microgynon / Ganfeborole + Microgynon Group

Microgynon DRUG

Participants receive Microgynon orally.

Microgynon / Ganfeborole + Microgynon Group

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participant is 18 to \<65 years of age, inclusive, at the time of signing the informed consent.
• Participants who are healthy as determined by the investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring (history and ECG).
• A creatinine clearance of \>=75 mL/min.
• Normal echocardiogram or echocardiogram with normal left ventricular function with at most trace to mild valvular regurgitation is allowed and no valvular stenosis.
• 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).
• 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.
• 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.
• Two FSH tests
• Negative pregnancy test

You may not qualify if:

• History of known cardiac valve abnormalities
• Medical history of fatty liver disease
• Major health conditions (including ovarian, endometrial, cervical, and breast tumours as per the Microgynon label)
• History of ovarian, endometrial, cervical and breast cancer
• History of deep vein thrombosis (DVT)
• Presence of hepatitis B surface antigen at Screening or within 3 months prior to starting study treatment.
• 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.
• Positive HIV-1 and/or -2 antigen/antibody immunoassay at Screening.
• Alanine aminotransferase (ALT) \>1.5×ULN. A single repeat of ALT is allowed within a single screening period to determine eligibility.
• Bilirubin \>1.5×ULN (isolated bilirubin \>1.5×ULN is acceptable if bilirubin was fractionated and direct bilirubin \<35%).
• Any acute laboratory abnormality at Screening which, in the opinion of the investigator, should preclude participation in the study of an investigational compound.
• Participants with haemoglobin \<8.0 g/dL.
• Any Grade 3 to 4 laboratory abnormality at Screening, inclusive of creatine phosphokinase and lipid abnormalities and ALT, excludes a participant from the study unless the investigator provided a compelling explanation for the laboratory result(s) and has the assent of the sponsor. A single repeat of any laboratory abnormality is allowed within a single screening period to determine eligibility.
• A positive test result for drugs of abuse (including marijuana), alcohol, or cotinine (indicating active current smoking) at Screening or before the first dose of study treatment.
• Unable to refrain from the use of prescription (including HRT), or non-prescription drugs including vitamins, herbal and dietary supplements (including St John's wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study treatment and for the duration of the study. Concomitant medications may be permitted on a case by case basis on the discretion of the medical monitor and the GSK Ganfeborole team.

Sponsors & Collaborators

• GlaxoSmithKline: lead
• UNITE4TB consortium: collaborator

MeSH Terms

Conditions

Tuberculosis

Interventions

GSK656; ethinyl estradiol, levonorgestrel drug combination

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Central Study Contacts

US GSK Clinical Trials Call Center

CONTACT

877-379-3718; GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center

CONTACT

+44 (0) 20 89904466; GSKClinicalSupportHD@gsk.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: This is an open-label study.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2026
• First Posted: August 25, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): November 24, 2026
• Study Completion (Estimated): November 24, 2026
• Last Updated: August 25, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or asset(s) with development terminated across all indications.
• Access Criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months, but an extension may be granted, when justified, for up to 6 months.