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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

ConditionTuberculosis
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexFemale
Age18-64
SponsorGlaxoSmithKline

About this trial

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

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Ganfeborole

    Drug

    Participants receive Ganfeborole orally.

  • Microgynon

    Drug

    Participants receive Microgynon orally.

Treatment groups

28 Participants
are divided into 1 treatment group
Group A: Microgynon / Ganfeborole + Microgynon GroupExperimental treatment 2 interventions

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

GlaxoSmithKline

Lead sponsor

UNITE4TB consortium

Collaborator

Source ClinicalTrials.gov
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