Infections, Human Immunodeficiency Virus and HepatitisPhase 1NCT02159131

Study to Evaluate the Pharmacokinetics of an Oral Contraceptive Containing Levonorgestrel and Ethinyl Estradiol When Co-administered With GSK1265744 in Healthy Adult Female Subjects

A Phase 1 study testing Ethinyl Estadiol, Levonorgestrel and GSK1265744 in people with Infections, Human Immunodeficiency Virus and Hepatitis, run by ViiV Healthcare at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for: Infections, Human Immunodeficiency Virus and Hepatitis
What is being tested?: Ethinyl Estadiol, Levonorgestrel and GSK1265744
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteUnited Kingdom
Study dates: Aug 2014to Dec 2014
Phase: Phase 1
Are there results?: None posted in the registry

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 45 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

Healthy female subjects, as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring.
Females aged between 18 and 45 years of age inclusive, at the time of signing the informed consent.
A female subject is eligible to participate if she is of: Child-bearing potential with negative pregnancy test as determined by serum hCG test at screening AND agrees to use one of the contraception methods listed in the protocol in addition to OC (containing levonorgestrel and ethinyl estradiol ) from Day 1 of the Run-In Period (if required) or Day 1 of Treatment Period 1 until 14 days after the last dose of study drug to sufficiently minimize the risk of pregnancy. Female subjects must agree to use an additional form of contraception throughout the study and for the subsequent post-study follow-up period OR Has only same-sex partners, when this is her preferred and usual lifestyle.
Female subject's with a body mass index (BMI) of 18to 30 kilogram per meter square (kg/m^2) and body weight >=50 kg (110 pounds [lbs]) and <114 kg (<250 lbs).
Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form
Alanine transaminase (ALT), alkaline phosphatase and bilirubin <=1.5x upper limit of normal (ULN) (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).

Who cannot join

History of any condition that would contraindicate OC administration (which may include hypertension, stroke, ischemic heart disease, venous thromboembolism or family history of thromboembolism, known factor V Leiden mutation or other gene mutations associated with increased risk of thromboembolism, migraine headaches, carcinoma of the breast, liver or endometrium, gallbladder disease, history of undiagnosed abnormal uterine bleeding, etc.).
Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
History of regular alcohol consumption within 6 months of the study defined as: an average weekly intake of >14 units for females. One unit is equivalent to 8 grams of alcohol: a half-pint (~240 milliliter [mL]) of beer, 1 glass (125 mL) of wine or 1 (25 mL) measure of spirits.
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 GlaxoSmithKline (GSK) Medical Monitor, contraindicates their participation.
A positive pre-study Hepatitis B surface antigen (or positive Hepatitis B core antibody with negative hepatitis B surface antibody) or positive Hepatitis C antibody result within 3 months of screening
A positive pre-study drug/alcohol screen.

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A positive test for Human immunodeficiency virus (HIV) antibody.
The subject's systolic blood pressure is outside the range of 80-140 millimeter of mercury (mmHg), or diastolic blood pressure is outside the range of 45-90mmHg.
Exclusion criteria for screening ECG (Heart rate: <50 and >100 beats per minute [bpm], PR Interval: <120 and >220 milliseconds [msec], QRS duration: <70 and >120 msec, QTc interval [Bazett]: >450 msec): evidence of previous myocardial infarction (Does not include ST segment changes associated with repolarization); any conduction abnormality (including but not specific to left or right complete bundle branch block, atrioventricular (AV) block [2nd degree or higher], Wolf Parkinson White [WPW] syndrome); sinus pauses > 3 seconds; any significant arrhythmia which, in the opinion of the principal investigator and GSK medical monitor, will interfere with the safety for the individual subject; non-sustained or sustained ventricular tachycardia (>=3 consecutive ventricular ectopic beats).
Use of prescription 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 medication, unless in the opinion of the Investigator and GSK Medical Monitor the medication will not interfere with the study procedures or compromise subject safety.
Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
Lactating females.
Unwillingness or inability to follow the procedures outlined in the protocol.
Subject is mentally or legally incapacitated.
The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
Women of childbearing potential who are unwilling or unable to use an appropriate method of contraception (see inclusion criteria) from at least Day 1 of the Run-in Period (if needed) or Day 1 of Treatment Period 1 until 14 days after the last dose of 744.
Current or recent (within 6 months) users of tobacco-containing products.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

GSK Investigational Site
London, SE1 1YR

Other trials in United Kingdom

About this study

Official title: An Open-label Study to Evaluate the Pharmacokinetics of an Oral Contraceptive Containing Levonorgestrel and Ethinyl Estradiol When Co-administered With GSK1265744 in Healthy Adult Female Subjects

This open-label, fixed-sequence crossover study aims to evaluate the effect of GSK1265744 (744) oral administration on the pharmacokinetics (PK) and pharmacodynamics (PD) of a commonly used oral contraceptive (OC) product (combination of ethinyl estradiol and levonorgestrel), in 20 healthy female subjects. Each subject will participate in a Run-in Period (if needed), followed by a single-sequence Treatment Period. Subjects will receive oral contraceptive containing Levonorgestrel and Ethinyl Estradiol on Days 1 to 21 and be OC free on Days 22 to 28, during which withdrawal menses should occur. Subjects will receive OC alone on Days 1 to 10. Levonorgestrel (LNG) and ethinyl estradiol (EE) PK will be determined on Day 10. Subjects will then co-administer 744 and OC on Days 11 to 21. Levonorgestrel and ethinyl estradiol PK will be determined again on Day 21 to assess if co-administration with 744 results in a significant change in OC exposure compared to OC alone. Subjects will return to the study center for final follow-up evaluations 7 to 14 days after the last dose of study medication (Days 28 to 35).

Conditions: Infections, Human Immunodeficiency Virus and Hepatitis
Being tested: Ethinyl Estadiol, Levonorgestrel, GSK1265744
Keywords: ethinyl estradiol, GSK1265744, pharmacokinetics, oral contraceptive, oral contraceptive containing levonorgestrel and ethinyl estradiol, levonorgestrel
Medical subject headings: Infections, Acquired Immunodeficiency Syndrome, Hepatitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Ethinyl EstadiolDrug
EE is available as a combination of EE 0.03 mg and LNG 0.15mg, a monophasic oral contraceptive tablet to be taken along with 240 mL water
LevonorgestrelDrug
LNG is available as a combination of EE 0.03 mg and LNG 0.15mg, a monophasic oral contraceptive tablet to be taken along with 240 mL water
GSK1265744Drug
GSK1265744 is available as 30 mg tablet to be taken along with 240 mL water

Study groups in NCT02159131
Study group	Role	What they receive
OC containing levonorgestrel and ethinyl estradiol + GSK126574	Experimental	Eligible subjects will enter a run-in-period of 21 days (may extend to 49 days) to stabilize on OC containing levonorgestrel and ethinyl estradiol in order to synchronize the menstrual cycles of multiple subjects. Subjects completing run-in-period will enter Treatment period 1 and will be dosed OC once daily on Days 1 to 10. At day 11 subjects will enter Treatment period 2 and will be dosed with OC containing levonorgestrel and ethinyl estradiol + 744 once daily on Day 12 to 19. Subjects completing Treatment period 2 will have 7 OC free days (Day 22 to 28) during which withdrawal menses should occur. Subjects will then be followed up for 7 to 14 days (Day 28 to 35/49). Receives: Drug: Ethinyl Estadiol; Drug: Levonorgestrel; Drug: GSK1265744

What is being measured

The primary outcome is the main question the study is designed to answer.

Plasma (AUC[0-tau])
Blood samples will be collected to estimate the area under the concentration-time curve over the dosing interval (AUC[0-tau]) of LNG and EE following OC with and without 744
Measured: Period 1: Predose on Day 9 and on Day 10: predose, and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, and 24 hours postdose. Period 2: Predose on Day 20 and on Day 21 predose, and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, and 24 hours postdose

Secondary outcomes (7)

Safety and tolerability of 744 when given with and without OC as assessed by adverse events (AE)
Safety and tolerability as assessed by number of participants with AEs
Measured: Up to 72 days
Safety and tolerability of 744 when given with and without OC as assessed by clinical laboratory tests
Safety laboratory parameters included hematology and clinical chemistry analysis and ECG
Measured: Up to 72 days
Safety and tolerability of 744 when given with and without OC as assessed by Electrocardiogram (ECG)
Measured: Up to 72 days
Safety and tolerability of 744 when given with and without OC as assessed by vital signs
Vital signs will include pulse rate and blood pressure measurements
Measured: Up to 72 days
Composite of plasma pharmacokinetic (PK) parameters of 744
Maximum observed plasma concentration (Cmax), plasma concentration at the end of the dosing interval (Ctau), time to maximum drug concentration (tmax), and oral clearance (CL/F) CL/F will be used to evaluate the pharmacokinetics of LNG and EE after OC alone and after OC with 744.
Measured: Period 1: Predose on Day 9 and on Day 10: predose, and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, and 24 hours postdose. Period 2: Predose on Day 20 and on Day 21 predose, and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, and 24 hours postdose
Predose serum levels of Progesterone, Luteinizing hormone (LH) and follicle stimulating hormone (FSH)
To assess the impact of 744 on the pharmacodynamic effects of OC on endogenous LH, FSH, and progesterone levels when given in combination compared with these parameters when OC is administered alone
Measured: At Screening and predose on Days 1, 10, 11, 21, and 22
Composite of plasma PK parameters of 744 - AUC(0-tau), Cmax, tmax, Ctau and CL/F
To evaluate the PK of 744 when co-administered with LNG and EE
Measured: Predose on Day 20 and on Day 21: predose and at 1, 2, 3, 4, 6, 8, 12, and 24 hours post dose on Day 22

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2014Dec 2014

First posted9 Jun 2014 (estimated)
Study startAug 2014
Primary completionDec 2014
Study completionDec 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Infections, Human Immunodeficiency Virus and HepatitisStudies of the same condition, open and under way.
More trials run by ViiV HealthcareThe 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
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02159131
Sponsor's protocol ID: 117011
Status last verified: Dec 2014
First submitted: 15 May 2014
Last updated: 7 Jul 2015
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 7 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label Study to Evaluate the Pharmacokinetics of an Oral Contraceptive Containing Levonorgestrel and Ethinyl Estradiol When Co-administered With GSK1265744 in Healthy Adult Female Subjects
ClinicalTrials.gov ID: NCT02159131
Acronym / sponsor ID: 117011
Conditions: Infections, Human Immunodeficiency Virus and Hepatitis
Keywords: ethinyl estradiol, GSK1265744, pharmacokinetics, oral contraceptive, oral contraceptive containing levonorgestrel and ethinyl estradiol, levonorgestrel
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: ViiV HealthcareIndustry (pharma, biotech, devices)
Study start: Aug 2014
Primary completion: Dec 2014 (actual)
Study completion: Dec 2014 (actual)
First posted: 9 Jun 2014 (estimated)
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.

Study design

Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
OC containing levonorgestrel and ethinyl estradiol + GSK126574	Experimental	Drug: Ethinyl Estadiol, Drug: Levonorgestrel, Drug: GSK1265744Eligible subjects will enter a run-in-period of 21 days (may extend to 49 days) to stabilize on OC containing levonorgestrel and ethinyl estradiol in order to synchronize the menstrual cycles of multiple subjects. Subjects completing run-in-period will enter Treatment period 1 and will be dosed OC once daily on Days 1 to 10. At day 11 subjects will enter Treatment period 2 and will be dosed with OC containing levonorgestrel and ethinyl estradiol + 744 once daily on Day 12 to 19. Subjects completing Treatment period 2 will have 7 OC free days (Day 22 to 28) during which withdrawal menses should occur. Subjects will then be followed up for 7 to 14 days (Day 28 to 35/49).

Who may qualify

Ages: 18 to 45 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (6 listed)

Healthy female subjects, as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring.
Females aged between 18 and 45 years of age inclusive, at the time of signing the informed consent.
A female subject is eligible to participate if she is of: Child-bearing potential with negative pregnancy test as determined by serum hCG test at screening AND agrees to use one of the contraception methods listed in the protocol in addition to OC (containing levonorgestrel and ethinyl estradiol ) from Day 1 of the Run-In Period (if required) or Day 1 of Treatment Period 1 until 14 days after the last dose of study drug to sufficiently minimize the risk of pregnancy. Female subjects must agree to use an additional form of contraception throughout the study and for the subsequent post-study follow-up period OR Has only same-sex partners, when this is her preferred and usual lifestyle.
Female subject's with a body mass index (BMI) of 18to 30 kilogram per meter square (kg/m^2) and body weight >=50 kg (110 pounds [lbs]) and <114 kg (<250 lbs).
Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form

Key exclusion criteria (18 listed)

History of any condition that would contraindicate OC administration (which may include hypertension, stroke, ischemic heart disease, venous thromboembolism or family history of thromboembolism, known factor V Leiden mutation or other gene mutations associated with increased risk of thromboembolism, migraine headaches, carcinoma of the breast, liver or endometrium, gallbladder disease, history of undiagnosed abnormal uterine bleeding, etc.).
Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
History of regular alcohol consumption within 6 months of the study defined as: an average weekly intake of >14 units for females. One unit is equivalent to 8 grams of alcohol: a half-pint (~240 milliliter [mL]) of beer, 1 glass (125 mL) of wine or 1 (25 mL) measure of spirits.
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 GlaxoSmithKline (GSK) Medical Monitor, contraindicates their participation.
A positive pre-study Hepatitis B surface antigen (or positive Hepatitis B core antibody with negative hepatitis B surface antibody) or positive Hepatitis C antibody result within 3 months of screening

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
Ethinyl EstadiolEE is available as a combination of EE 0.03 mg and LNG 0.15mg, a monophasic oral contraceptive tablet to be taken along with 240 mL water	Drug	OC containing levonorgestrel and ethinyl estradiol + GSK126574
LevonorgestrelLNG is available as a combination of EE 0.03 mg and LNG 0.15mg, a monophasic oral contraceptive tablet to be taken along with 240 mL water	Drug	OC containing levonorgestrel and ethinyl estradiol + GSK126574
GSK1265744GSK1265744 is available as 30 mg tablet to be taken along with 240 mL water	Drug	OC containing levonorgestrel and ethinyl estradiol + GSK126574

Primary outcome

Plasma (AUC[0-tau])
Time frame: Period 1: Predose on Day 9 and on Day 10: predose, and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, and 24 hours postdose. Period 2: Predose on Day 20 and on Day 21 predose, and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, and 24 hours postdose
Blood samples will be collected to estimate the area under the concentration-time curve over the dosing interval (AUC[0-tau]) of LNG and EE following OC with and without 744

7 secondary outcomes

Safety and tolerability of 744 when given with and without OC as assessed by adverse events (AE)
Time frame: Up to 72 days
Safety and tolerability of 744 when given with and without OC as assessed by clinical laboratory tests
Time frame: Up to 72 days
Safety and tolerability of 744 when given with and without OC as assessed by Electrocardiogram (ECG)
Time frame: Up to 72 days
Safety and tolerability of 744 when given with and without OC as assessed by vital signs
Time frame: Up to 72 days
Composite of plasma pharmacokinetic (PK) parameters of 744
Time frame: Period 1: Predose on Day 9 and on Day 10: predose, and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, and 24 hours postdose. Period 2: Predose on Day 20 and on Day 21 predose, and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, and 24 hours postdose
Predose serum levels of Progesterone, Luteinizing hormone (LH) and follicle stimulating hormone (FSH)
Time frame: At Screening and predose on Days 1, 10, 11, 21, and 22
Composite of plasma PK parameters of 744 - AUC(0-tau), Cmax, tmax, Ctau and CL/F
Time frame: Predose on Day 20 and on Day 21: predose and at 1, 2, 3, 4, 6, 8, 12, and 24 hours post dose on Day 22

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2015.

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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. This study is not recruiting at the moment.

GSK Clinical Trials study director

ViiV Healthcare

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 Ethinyl Estadiol, Levonorgestrel and GSK1265744 in people with Infections, Human Immunodeficiency Virus and Hepatitis, run by ViiV Healthcare at 1 site in United Kingdom.

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 6 inclusion and 18 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: finished, as of the sponsor's last update on 7 Jul 2015. 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 United Kingdom. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Plasma (AUC[0-tau]) (time frame: Period 1: Predose on Day 9 and on Day 10: predose, and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, and 24 hours postdose. Period 2: Predose on Day 20 and on Day 21 predose, and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, and 24 hours postdose). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02159131.

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 7 Jul 2015.