Last updated: 08/21/2026 09:40:35

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

GSK study ID
308245
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Trial status
Not yet recruiting
Not yet recruiting
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A Phase 1, Open-Label, Fixed Sequence, 1-Way Drug-Drug Interaction Study to Investigate the Repeat-Dose Pharmacokinetics of Microgynon, an Oral Contraceptive Containing Ethinyl Estradiol and Levonorgestrel, when Administered Alone and in Combination with Ganfeborole in Healthy Female Participants of Non-Childbearing Potential Aged 18-65 Years Old
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Single Group
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:

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

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: 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:

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

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: 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

Ctau over 24 hours of EE and LNG alone and in the presence of Ganfeborole

Timeframe: 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

Number of participants with serious adverse events (SAEs)

Timeframe: From Day 1 to Day 25

Number of participants with adverse events (AEs) of grade 3 severity or higher

Timeframe: From Day 1 to Day 25

Number of participants with any AEs related to study interventions, overall and by each type of treatment (Microgynon and Ganfeborole)

Timeframe: From Day 1 to Day 25

Number of participants withdrawn from the. treatment/study due to AEs

Timeframe: From Day 1 to Day 25

Number of participants with electrocardiogram (ECG) values of potential clinical importance (PCI)

Timeframe: At Day 11 and Day 25

Number of participants with clinical chemistry laboratory values of PCI

Timeframe: At Days 1, 7, 11, 21 and 25

Number of participants with hematology laboratory values of PCI

Timeframe: At Days 1, 7, 11, 21 and 25

Number of participants with vital signs parameters of systolic blood pressure (SBP), diastolic BP (DBP) and heart rate (HR) of PCI

Timeframe: At Days 1, 7, 11, 21 and 25

Change in sex hormone binding globulin (SHBG) levels following repeat-dose administration of Microgynon

Timeframe: At Screening, Day 10 and Day 24

Interventions:
Drug: Ganfeborole
Drug: Microgynon
Enrollment:
28
Observational study model:
Not applicable
Primary completion date:
2026-24-11
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Tuberculosis
Product
GSK3036656
Collaborators
UNITE4TB consortium
Study date(s)
September 2026 to November 2026
Type
Interventional
Phase
1

Participation criteria

Sex
Female
Age
18 - 64 Years
Accepts healthy volunteers
Yes
  • 1. Participant is 18 to <65 years of age, inclusive, at the time of signing the informed consent.
  • 2. 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).
  • 1. History of known cardiac valve abnormalities
  • 2. Medical history of fatty liver disease

Trial location(s)

No location data available.

Study documents

No study documents available.

Results overview

Study Results yet to be posted

Recruitment status
Not yet recruiting
Actual primary completion date
Not applicable
Actual study completion date
Not applicable

Plain language summaries

Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

Additional information about the trial

Additional information
Not applicable
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