A Study to Investigate the Pharmacokinetics of a Combined Oral Contraceptive When Given Alone and in Combination With GSK3036656 in Female Participants of Non-childbearing Potential Aged 18 to 65 Years of Age

NCT06354257 | Completed Phase 1 Results

• 1 other identifier: 220104
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to provide data showing if there are any effects of GSK3036656 on a combined oral contraceptive containing Ethinyl Estradiol (EE) and Levonorgestrel (LNG), which will help inform future studies on suitable contraceptive measures to be used.

Conditions

Tuberculosis

Keywords

Oral contraceptive; GSK3036656; Fixed sequence; Ethinyl Estradiol; Levonorgestrel; Drug interaction

Outcome Measures

Primary Outcomes (2)

• Area Under the Plasma Drug Concentration (AUC) From Time Zero Extrapolated to Infinity (AUC[0-inf]) After a Single Dose of EE and LNG

  AUC(0-inf) is defined as the area under the concentration-time curve from time 0 extrapolated to infinity and was calculated by using a non-compartmental analysis.

  At Day 1 for the Treatment Period 1: Microgynon Group and at Day 15 for the Treatment Period 3: Microgynon + GSK3036656 Group

• Maximum Observed Plasma Concentration (Cmax) After a Single Dose of EE and LNG

  Cmax is defined as the maximum observed plasma concentration determined directly from the concentration-time data and was calculated by using a non-compartmental analysis.

  At Day 1 for the Treatment Period 1: Microgynon Group and at Day 15 for the Treatment Period 3: Microgynon + GSK3036656 Group

Secondary Outcomes (16)

• AUC Versus Time Curve From Time Zero During a Dosage Interval of Time at Steady State [AUC(0-tau)] of GSK3036656 With EE/LNG

  At Day 15

• Cmax at Steady State of GSK3036656 With EE/LNG

  At Day 15

• Trough Plasma Concentration (Ctau) at Steady State of GSK3036656 With EE/LNG and GSK3036656 Alone

  At Day 8, 10, 12, 15 and 16

• Time to Maximum Observed Plasma Drug Concentration (Tmax) at Steady State of GSK3036656 With EE/LNG

  At Day 15

• AUC Versus Time Curve (AUC[0-t]) of EE and LNG Alone and With GSK3036656

  At Day 1 for the Treatment Period 1: Microgynon Group and at Day 15 for the Treatment Period 3: Microgynon + GSK3036656 Group

Study Arms (1)

Combined Participants Group

EXPERIMENTAL

Participants received a dose of Microgynon \[0.03 mg Ethinyl Estradiol (EE)/0.15 mg Levonorgestrel (LNG)\] on Day 1 of Treatment Period 1. In Treatment Period 2, they received GSK3036656 40 mg on Day 4 followed by GSK3036656 20 mg once daily from Day 5 to Day 14. In Treatment Period 3, participants received Microgynon (EE/LNG) along with GSK3036656 20 mg on Day 15, followed by GSK3036656 20 mg once daily from Day 16 to Day 17.

Drug: Microgynon; Drug: GSK3036656

Interventions

Microgynon DRUG

Participants received 1 dose of Microgynon (0.03 mg EE/0.15 mg LNG) on Day 1 of Treatment Period 1 and 1 dose co-administered with GSK3036656 20 mg on Day 15 of Treatment Period 3.

Combined Participants Group

GSK3036656 DRUG

Participants received 1 loading dose of 40 mg on Day 4 and a dose of 20 mg on Days 5 to 14 once daily in Treatment Period 2. In Treatment Period 3, participants received one 20 mg dose along with Microgynon (0.03 mg EE/0.15 mg LNG) on Day 15 after which a 20 mg dose on Days 17 and 18 once daily.

Combined Participants Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age:
• Participant was 18 to 65 years of age, inclusive, at the time of signing the informed consent.
• Type of Participant and Disease Characteristics:
• Participants were healthy or compensated, 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).
• Creatinine clearance was \>= 75 mL/min.
• Echocardiogram was normal or showed normal left ventricular function; at most trace to mild valvular regurgitation was allowed, with no valvular stenosis.
• Weight:
• Body weight was \>= 45.0 kg (99 lbs), and body mass index was within the range 18.5 to 31.0 kg/m² (inclusive).
• Sex:
• Female participants were of Nonchildbearing Potential (WONCBP).
• Women in the following categories were considered WONCBP:
• Permanently sterile due to one of the following procedures:
• Documented hysterectomy.
• Documented bilateral salpingectomy.
• Documented bilateral oophorectomy.

You may not qualify if:

• Medical History:
• History of known cardiac valve abnormalities.
• Laboratory Assessments:
• 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 -2 antigen/antibody immunoassay at Screening.
• Alanine aminotransferase (ALT) \> 1.5×ULN. A single repeat of ALT was allowed within a single screening period to determine eligibility.
• Bilirubin \> 1.5×ULN (isolated bilirubin \> 1.5×ULN was acceptable if bilirubin was fractionated and direct bilirubin was \< 35%).
• Any acute laboratory abnormality at Screening which, in the opinion of the investigator, should have precluded participation in the study of an investigational compound.
• Participants with haemoglobin \< 8.0 g/dL.
• Any Grade 2 to 4 laboratory abnormality at Screening-except creatine phosphokinase, lipid abnormalities, and ALT (as above)-excluded a participant unless the investigator provided a compelling explanation and had sponsor assent. A single repeat of any laboratory abnormality was allowed within a single screening period.
• Positive test result for drugs of abuse (including marijuana), alcohol, or cotinine at Screening or before the first study dose.
• Prior/Concomitant Therapy:
• Participants were unable to refrain from using prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's wort), within 7 days prior to the first dose and throughout the study.
• Levothyroxine and omeprazole were allowed if participants had been on a stable dose for \>= 1 month prior to Treatment Period 1 and maintained the same dose. Microgynon was administered \>= 1 hour after levothyroxine or omeprazole. Other medications were allowed on a case-by-case basis with medical monitor and GSK ganfeborole team approval.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Madrid, 28046, Spain

Location

MeSH Terms

Conditions

Tuberculosis

Interventions

ethinyl estradiol, levonorgestrel drug combination; GSK656

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

866-435-7343

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: Open-label
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Fixed sequence

Study Record Dates

• First Submitted: April 3, 2024
• First Posted: April 9, 2024
• Study Start: April 5, 2024
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: August 26, 2025
• Results First Posted: August 26, 2025

Record last verified: 2025-08

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 terminated asset(s) 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.

Locations

ES (1)