TuberculosisPhase 1NCT07784894
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 study testing Ganfeborole and Microgynon in people with Tuberculosis, run by GlaxoSmithKline at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 64 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Tuberculosis
- What is being tested?
- Ganfeborole and Microgynon
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteSpain
- Study dates
- 20 Aug 2026to 17 Nov 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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.
- Additional inclusion criteria:
- Two FSH tests
- Negative pregnancy test
Who cannot join
- 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.
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- 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.
- Treatment with any vaccine within 30 days prior to receiving study treatment.
- 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.
- 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.
- 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).
- Where participation in the study results in donation of blood or blood products in excess of 500 mL within 56 days.
- Any significant arrhythmia or ECG finding which would interfere with the safety for the individual participant
- Exclusion criteria for screening ECG (a single repeat is allowed for eligibility determination): Heart rate: <50 or >100 beats per minute; QTcF interval: >450 milliseconds; QTcF interval (Bundle Branch Block): >480 milliseconds.
- Participants with vitiligo.
- Participants with hypertension or Type 2 diabetes that cannot be controlled with diet and exercise alone.
- 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.
- Unable to refrain from tobacco- or nicotine-containing products.
- 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.
- 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.
- Cardiac safety exclusion criteria:
- QTcF >450 milliseconds or QTcF >480 milliseconds for patients with bundle branch block.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
GSK Investigational Site
Madrid, 28046
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
About this study
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
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
- Being tested
- Ganfeborole, Microgynon
- Keywords
- Ganfeborole, GSK3036656, Microgynon, Ethinylestradiol and Levonorgestrel, Drug-drug interaction (DDI), Non-childbearing potential, Tuberculosis (TB)
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GanfeboroleDrug
Also called GSK3036656
Participants receive Ganfeborole orally.
MicrogynonDrug
Participants receive Microgynon orally.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Ganfeborole; Drug: Microgynon |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
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.
Measured: From Day 1 to Day 25
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.
Measured: 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)
Measured: From Day 1 to Day 25
Number of participants withdrawn from the. treatment/study due to AEs
Measured: From Day 1 to Day 25
Number of participants with electrocardiogram (ECG) values of potential clinical importance (PCI)
Measured: At Day 11 and Day 25
Number of participants with clinical chemistry laboratory values of PCI
Measured: At Days 1, 7, 11, 21 and 25
Number of participants with hematology laboratory values of PCI
Measured: 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
Measured: At Days 1, 7, 11, 21 and 25
Change in sex hormone binding globulin (SHBG) levels following repeat-dose administration of Microgynon
Measured: At Screening, Day 10 and Day 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2026
- Study start20 Aug 2026
- Primary completion17 Nov 2026 (estimated)
- Study completion17 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- UNITE4TB consortium
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07784894
- Sponsor's protocol ID
- 308245
- Other IDs
- 2026-525790-39
- Status last verified
- Sep 2026
- First submitted
- 21 Aug 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07784894
- Acronym / sponsor ID
- 308245
- Conditions
- Tuberculosis
- Keywords
- Ganfeborole, GSK3036656, Microgynon, Ethinylestradiol and Levonorgestrel, Drug-drug interaction (DDI), Non-childbearing potential, Tuberculosis (TB)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Collaborators
- UNITE4TB consortium
- Study start
- 20 Aug 2026 (actual)
- Primary completion
- 17 Nov 2026 (estimated)
- Study completion
- 17 Nov 2026 (estimated)
- First posted
- 25 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Microgynon / Ganfeborole + Microgynon Group | Experimental | Drug: Ganfeborole, Drug: MicrogynonParticipants 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. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- 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).
Key exclusion criteria (36 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GanfeboroleAlso: GSK3036656Participants receive Ganfeborole orally. | Drug | Microgynon / Ganfeborole + Microgynon Group |
| MicrogynonParticipants receive Microgynon orally. | Drug | Microgynon / Ganfeborole + Microgynon Group |
Primary outcome
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
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
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
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
15 secondary outcomes
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
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
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
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
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
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
Number of participants with serious adverse events (SAEs)
Time frame: From Day 1 to Day 25
Number of participants with adverse events (AEs) of grade 3 severity or higher
Time frame: 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)
Time frame: From Day 1 to Day 25
Number of participants withdrawn from the. treatment/study due to AEs
Time frame: From Day 1 to Day 25
Number of participants with electrocardiogram (ECG) values of potential clinical importance (PCI)
Time frame: At Day 11 and Day 25
Number of participants with clinical chemistry laboratory values of PCI
Time frame: At Days 1, 7, 11, 21 and 25
Number of participants with hematology laboratory values of PCI
Time frame: 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
Time frame: At Days 1, 7, 11, 21 and 25
Change in sex hormone binding globulin (SHBG) levels following repeat-dose administration of Microgynon
Time frame: At Screening, Day 10 and Day 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Individual participant dataSharing planned: 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ganfeborole and Microgynon in people with Tuberculosis, run by GlaxoSmithKline at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact US GSK Clinical Trials Call Center (877-379-3718, GSKClinicalSupportHD@gsk.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.