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RecruitingNCT07784894Updated Oct 2, 2026

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

A Phase 1 interventional study of Ganfeborole and Microgynon in Tuberculosis, sponsored by GlaxoSmithKline. Recruiting at 1 site in Spain. Open to female participants aged 18 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-02.

Sponsored by GlaxoSmithKline · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Started Aug 2026; still recruiting 2 months later.
Updated Oct 2, 2026Now RecruitingFirst site in Spain+4 moreGo to Updates ↓
Phase
Phase 1
Study type
Interventional
Enrollment
28
Allocation
Not applicable
Ages
18 Years to 64 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Tuberculosis

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Keywords

  • Ganfeborole
  • GSK3036656
  • Microgynon
  • Ethinylestradiol and Levonorgestrel
  • Drug-drug interaction (DDI)
  • Non-childbearing potential
  • Tuberculosis (TB)
03

In context

Tuberculosis

1,170 studies on the registry are indexed under Tuberculosis; 175 are open to participants now.

This study's planned enrollment of 28 is below the median of 150 across 820 interventional studies indexed under Tuberculosis.

Browse Tuberculosis studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,650 studies on the registry; 118 are open to participants now.

Of its 264 completed or terminated interventional studies of FDA-regulated products, 241 (91%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 64 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Participant is 18 to \<65 years of age, inclusive, at the time of signing the .
  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 ).
  3. A of >=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 within the range 18.5 up to 30.0 kg/m\^2 (inclusive).
  6. Participant of Non-. Participants in the following categories are considered female PONCBP: 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 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

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 surface antigen at Screening or within 3 months prior to starting study treatment.
  7. Positive antibody test result at Screening or within 3 months prior to starting study treatment AND positive on reflex to hepatitis C RNA.
  8. Positive -1 and/or -2 antigen/antibody immunoassay at Screening.
  9. (ALT) >1.5×. A single repeat of ALT is allowed within a single screening period to determine eligibility.
  10. >1.5×ULN (isolated bilirubin >1.5×ULN is acceptable if bilirubin was fractionated and direct bilirubin \<35%).
  11. Any acute laboratory abnormality at Screening which, in the opinion of the investigator, should preclude participation in the study of an compound.
  12. Participants with \<8.0 g/dL.
  13. 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.
  14. 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.
  15. 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.
  16. Treatment with any vaccine within 30 days prior to receiving study treatment.
  17. Unwillingness to abstain from excessive consumption of any food or drink containing caffeine, grapefruit or grapefruit juice, Seville oranges, blood oranges, or pomelos or their fruit juices within 7 days prior to the first dose of study treatment(s) until the end of the study.
  18. The study will exclude participants who have undergone IVF or other assisted reproductive techniques within 9 months prior to screening or are participating in such programs at the time of screening, or who plan to undergo IVF or other assisted reproductive techniques during the following year.
  19. Participation in another concurrent clinical study or prior clinical study (with the exception of imaging trials) prior to the first dosing day in the current study: 30 days, 5 half-lives plus 10 days, or twice the duration of the biological effect of the investigational product (whichever is longer).
  20. Where participation in the study results in donation of blood or blood products in excess of 500 mL within 56 days.
  21. Any significant arrhythmia or finding which would interfere with the safety for the individual participant
  22. Exclusion criteria for screening ECG (a single repeat is allowed for eligibility determination): Heart rate: \<50 or >100 beats per minute; interval: >450 milliseconds; QTcF interval (Bundle Branch Block): >480 milliseconds.
  23. Participants with vitiligo.
  24. Participants with hypertension or Type 2 diabetes that cannot be controlled with diet and exercise alone.
  25. History of regular alcohol consumption within 6 months of the study defined as: an average weekly intake of >14 units. One unit is equivalent to 8 g of alcohol: a half pint (\~240 mL) of beer, 1 glass (125 mL) of wine or 1 (25 mL) measure of spirits.
  26. Unable to refrain from tobacco- or nicotine-containing products.
  27. History of sensitivity to any of the study medications, or components thereof, or a history of drug or other allergy that, in the opinion of the investigator or medical monitor, contraindicates their participation.
  28. Liver safety exclusion criteria:

    • ALT >1.5xULN.
    • Total bilirubin >1.5xULN; Participants with Gilbert's syndrome can be included with total bilirubin >1.5xULN if direct bilirubin is \<=1.5xULN.
    • Current or chronic history of liver disease (including fatty liver disease) or known hepatic or biliary abnormalities (except for Gilbert's syndrome or asymptomatic gallstones).
    • Presence of hepatitis B surface antigen (HBsAg) at screening or within 3 months prior to first dose of study intervention.
    • Positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study intervention.
    • Positive hepatitis C RNA test result at screening or within 3 months prior to first dose of study intervention.
  29. Cardiac safety exclusion criteria:

    • QTcF >450 milliseconds or QTcF >480 milliseconds for patients with bundle branch block.
Terms in these criteria, in plain language(16)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
28 participants (estimated)

Study arms

  • Experimental
    Microgynon / Ganfeborole + Microgynon Group

    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

  • DrugGanfeborole

    Participants receive Ganfeborole orally.

    Also known as: GSK3036656

  • DrugMicrogynon

    Participants receive Microgynon orally.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 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

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

    Time frame: 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

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

    Time frame: 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

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

    Time frame: 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

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

    Time frame: 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

  2. Cmax of Ganfeborole in the presence of EE and LNG

    Time frame: 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

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

    Time frame: 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

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

    Time frame: 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

  5. Tmax of EE and LNG alone and in the presence of Ganfeborole

    Time frame: 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

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

    Time frame: 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

  7. Number of participants with serious adverse events (SAEs)

    An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, or other situations as per investigator's opinion.

    Time frame: From Day 1 to Day 25

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

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. Grade 3 = severe, Grade 4 = life-threatening, Grade 5= death.

    Time frame: From Day 1 to Day 25

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

    Time frame: From Day 1 to Day 25

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

    Time frame: From Day 1 to Day 25

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

    Time frame: At Day 11 and Day 25

  12. Number of participants with clinical chemistry laboratory values of PCI

    Time frame: At Days 1, 7, 11, 21 and 25

  13. Number of participants with hematology laboratory values of PCI

    Time frame: At Days 1, 7, 11, 21 and 25

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

    Time frame: At Days 1, 7, 11, 21 and 25

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

    Time frame: At Screening, Day 10 and Day 24

07

Study locations

1 of 1 sites recruiting
  • GSK Investigational Site
    Madrid, 28046, Spain
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes — Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://d3l8i7lo48obsd.cloudfront.net/gsk-patient-level-data-sharing-july2025-1-Bgwa1UthxvluYbWYTThw.pdf

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report

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.

Data sharing details ↗ · www.gsk-studyregister.com

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Status
Not yet recruiting→Recruiting
changed Oct 2, 2026
Sites
1 site added — first site in Spain
Show site
  • GSK Investigational Site · Madrid, Spain
Oct 2, 2026
Start date
Sep 1, 2026→Aug 20, 2026 (actual)
Oct 2, 2026
Primary completion
Nov 24, 2026→Nov 17, 2026
Oct 2, 2026
Study completion
Nov 24, 2026→Nov 17, 2026
Oct 2, 2026
Show all 1 update
  1. Oct 2, 2026
    Not yet recruiting→Recruiting
    1 site added — first site in Spain
    Show site
    • GSK Investigational Site · Madrid, Spain
    Start date Sep 1, 2026→Aug 20, 2026 (now actual)
    Primary completion Nov 24, 2026→Nov 17, 2026
    Study completion Nov 24, 2026→Nov 17, 2026
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07784894
Lead sponsor
GlaxoSmithKline
Collaborators
UNITE4TB consortium
Responsible party
Sponsor
First posted
Aug 25, 2026
Start date
Aug 20, 2026
Primary completion
Nov 17, 2026 (estimated)
Completion
Nov 17, 2026 (estimated)
Last update
Oct 2, 2026

Study contacts

US GSK Clinical Trials Call Center
Contact
GSKClinicalSupportHD@gsk.com
877-379-3718
EU GSK Clinical Trials Call Center
Contact
GSKClinicalSupportHD@gsk.com
+44 (0) 20 89904466

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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