Embryo TransferPhase 1NCT01669083

Study to Evaluate the Pharmacokinetics, Safety and Tolerability of GSK557296 in Healthy Women Volunteers After Single and Repeat Dosing

A Phase 1 study testing GSK557296 10 mg, GSK557296 150 mg and GSK557296 dose 3 in people with Embryo Transfer, run by GlaxoSmithKline at 1 site in United States.

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: Embryo Transfer
What is being tested?: GSK557296 10 mg, GSK557296 150 mg and GSK557296 dose 3
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 36 participants
Where: 1 siteUnited States
Study dates: 16 Aug 2012to 9 Mar 2013
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

Alanine aminotransferase (ALT), alkaline phosphatase and bilirubin <=1.5xupper limit of normal (ULN)
Single or QTcF < 450 millisecond (msec); or QTc < 480 msec in subjects with Bundle Branch Block
Healthy as determined by a responsible and experienced physician
Female 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 and is abstinent or agrees to use contraception methods to sufficiently minimize the risk of pregnancy during the study.
Body weight >= 50 kilogram (kg) and Body Mass Index (BMI) within the range 19 to 29.9 kg per meter^2 (inclusive)

Who cannot join

A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result at screening or within 3 months of screening
Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)
A positive pre-study drug or alcohol screen
A positive test for HIV antibody
History of regular alcohol consumption within 6 months of the study
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 Unable to refrain from the use of prescription or non-prescription drugs, with the exception of Oral contraceptives, within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication 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 GSK Medical Monitor, contraindicates their participation

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Where participation in the study would result in donation of blood or blood products in excess of 500 milliliter (mL) within a 56 day period
Pregnant females
Lactating females
Unwillingness or inability to follow the procedures outlined in the protocol
Subject is mentally or legally incapacitated
Urinary cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products within 6 months prior to screening
Unable to refrain from consumption of red wine, seville oranges, grapefruit or grapefruit juice and/or pomelos, exotic citrus fruits, grapefruit hybrids or fruit juices from 7 days prior to the first dose of study medication

Trial locations and contacts

1 site in 1 country.

United States1 site

GSK Investigational Site
Baltimore, Maryland, 21225

Other trials in United States

About this study

Official title: A Phase I Non-Randomized Multi Cohort, Open Label, Bridging Study to Evaluate the Pharmacokinetics, Safety and Tolerability of GSK557296 in Healthy Women Volunteers After Single and Repeat Dosing

GSK557296 is being studied in women for the indication of enhanced embryo and or blastocyst implantation in women undergoing IVF treatment. This study will be the first dosing experience with this compound in women. It is important to characterize the pharmacokinetics of GSK557296 in women to determine the most appropriate doses and dosing regimens for future clinical studies. Understanding the pharmacokinetics of GSK557296 in women will also enable more accurate characterization of any exposure-response relationship in future studies.

Two previous studies with GSK557296 were conducted in men with oral doses ranging from 10 milligram (mg) to 200 mg. GSK557296 is being studied in women for the indication of enhanced embryo and or blastocyst implantation in women undergoing IVF treatment. This is a bridging study to characterize the pharmacokinetics of GSK557296 in women to determine the most appropriate doses and dosing regimens for future clinical studies.

This is a non-randomized, open label, adaptive design study in healthy female volunteers. A maximum total of 48 subjects, will participate in different cohorts. Subjects in Cohort 1 will receive 10 mg single dose followed by repeat dose. A one week break will occur to allow for analysis of the PK data, prior to starting the second Cohort. Subjects in Cohort 2 will receive 150 mg single dose followed by repeat dose. Cohort 3 and Cohort 4 were adaptive based on the requirement of additional doses to be studies after PK data will be analyzed from each of the first 2 cohorts.

Conditions: Embryo Transfer
Being tested: GSK557296 10 mg, GSK557296 150 mg, GSK557296 dose 3, GSK557296 dose 4
Keywords: Oxytocin Antagonist, Embryo/Blastocyst Implantation

What participants receive

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

GSK557296 10 mgDrug
10 mg single oral dose. Each subject will receive 2 tablets of 5 mg GSK557296 four times a day (QID).
GSK557296 150 mgDrug
150 mg single oral dose. Each subject will receive multiple tablets of 25 mg GSK557296 either 2, 3 or 4 times a day.
GSK557296 dose 3Drug
Dose to be determined as a single dose tablet based on half-life demonstrated in Cohort 1 and Cohort 2.
GSK557296 dose 4Drug
Dose to be determined by PK of prior doses, based on half-life demonstrated in prior cohorts.

Study groups in NCT01669083
Study group	Role	What they receive
Cohort 1: GSK557296 10 mg	Experimental	GSK557296 10 mg single dose on Day 1 followed by repeat dosing (4 times a day) on Days 2-6 Receives: Drug: GSK557296 10 mg
Cohort 2: GSK557296 150 mg	Experimental	GSK557296 150 mg as a single dose on Day 1 followed by repeat nominal dosing of the same dose (either 2, 3 or 4 times a day based on half-life demonstrated in treatment A) on Days 9-13 Receives: Drug: GSK557296 150 mg
Cohort 3	Experimental	This study had an adaptive design and additional cohorts may be added depending on the PK profiles of Cohort 1 and Cohort 2. Subjects in this optional Cohort 3 will receive GSK557296 (dose to be determined) as a single dose on Day 1 followed by repeat nominal dosing of the same dose (either 2, 3 or 4 times a day based on half-life demonstrated in Cohort 1 and Cohort 2) on Days 2-6 Receives: Drug: GSK557296 dose 3
Cohort 4	Experimental	This study had an adaptive design and additional cohorts may be added depending on the PK profiles of Cohort 1 and Cohort 1. Subjects in this optional Cohort 4 will receive GSK557296 (dose to be determined) by PK of prior doses, 10-150 mg single dose on Day 1 followed by repeat dosing (either 2, 3 or 4 times a day dependent on half-life demonstrated in prior groups) on Days 2-6 Receives: Drug: GSK557296 dose 4

What is being measured

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

Composite of PK parameters of 20 mg GSK557296 following single and repeat oral dosing
From the plasma concentration-time data, the following PK parameters will be determined: maximum observed plasma concentration (Cmax), time to Cmax (tmax), area under the plasma concentration-time curve [AUC(0-t) and AUC(0-infinity)], and apparent terminal phase half-life (t1/2). AUC(0-infinity) or AUC(0-τ) and Cmax following single and repeat doses may be used for assessment of dose proportionality.
Measured: 7 days
Composite of PK parameters of 150 mg GSK557296 following single and repeat oral dosing
From the plasma concentration-time data, the following PK parameters will be determined: maximum observed plasma concentration (Cmax), time to Cmax (tmax), area under the plasma concentration-time curve [AUC(0-t) and AUC(0-infinity)], and apparent terminal phase half-life (t1/2). AUC(0- infinity) or AUC(0-τ) and Cmax following single and repeat doses may be used for assessment of dose proportionality.
Measured: 14 days
Safety and tolerability of GSK557296 following single and repeat dosing
Safety and tolerability parameters assessments include adverse events, clinical laboratory, ECG, vital signs, and concurrent medication
Measured: up to 49 days

Timeline

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

16 Aug 20129 Mar 2013

First posted20 Aug 2012 (estimated)
Study start16 Aug 2012
Primary completion9 Mar 2013
Study completion9 Mar 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Embryo TransferStudies 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: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 36 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01669083
Sponsor's protocol ID: 116741
Status last verified: Jun 2017
First submitted: 16 Aug 2012
Last updated: 7 Jun 2017
Results posted: No
Data monitoring committee: No
Individual data sharing: Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Publications

Mahar KM, Stier B, Fries M, McCallum SW. A single- and multiple-dose study to investigate the pharmacokinetics of epelsiban and its metabolite, GSK2395448, in healthy female volunteers. Clin Pharmacol Drug Dev. 2015 Nov;4(6):418-26. doi: 10.1002/cpdd.210. Epub 2015 Aug 26.
PubMed 27137713

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?

See locations

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RecruitingPhase 2
Effect of FB301 on Vaginal Bacterial Profile in Women With Asymptomatic Vaginal Dysbiosis Undergoing a Mock Frozen Embryo Transfer Cycle
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All Embryo Transfer trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I Non-Randomized Multi Cohort, Open Label, Bridging Study to Evaluate the Pharmacokinetics, Safety and Tolerability of GSK557296 in Healthy Women Volunteers After Single and Repeat Dosing
ClinicalTrials.gov ID: NCT01669083
Acronym / sponsor ID: 116741
Conditions: Embryo Transfer
Keywords: Oxytocin Antagonist, Embryo/Blastocyst Implantation
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 36 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 16 Aug 2012 (actual)
Primary completion: 9 Mar 2013 (actual)
Study completion: 9 Mar 2013 (actual)
First posted: 20 Aug 2012 (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

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Cohort 1: GSK557296 10 mg	Experimental	Drug: GSK557296 10 mgGSK557296 10 mg single dose on Day 1 followed by repeat dosing (4 times a day) on Days 2-6
Cohort 2: GSK557296 150 mg	Experimental	Drug: GSK557296 150 mgGSK557296 150 mg as a single dose on Day 1 followed by repeat nominal dosing of the same dose (either 2, 3 or 4 times a day based on half-life demonstrated in treatment A) on Days 9-13
Cohort 3	Experimental	Drug: GSK557296 dose 3This study had an adaptive design and additional cohorts may be added depending on the PK profiles of Cohort 1 and Cohort 2. Subjects in this optional Cohort 3 will receive GSK557296 (dose to be determined) as a single dose on Day 1 followed by repeat nominal dosing of the same dose (either 2, 3 or 4 times a day based on half-life demonstrated in Cohort 1 and Cohort 2) on Days 2-6
Cohort 4	Experimental	Drug: GSK557296 dose 4This study had an adaptive design and additional cohorts may be added depending on the PK profiles of Cohort 1 and Cohort 1. Subjects in this optional Cohort 4 will receive GSK557296 (dose to be determined) by PK of prior doses, 10-150 mg single dose on Day 1 followed by repeat dosing (either 2, 3 or 4 times a day dependent on half-life demonstrated in prior groups) on Days 2-6

Who may qualify

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

Key inclusion criteria (6 listed)

Alanine aminotransferase (ALT), alkaline phosphatase and bilirubin <=1.5xupper limit of normal (ULN)
Single or QTcF < 450 millisecond (msec); or QTc < 480 msec in subjects with Bundle Branch Block
Healthy as determined by a responsible and experienced physician
Female 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 and is abstinent or agrees to use contraception methods to sufficiently minimize the risk of pregnancy during the study.

Key exclusion criteria (13 listed)

A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result at screening or within 3 months of screening
Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)
A positive pre-study drug or alcohol screen
A positive test for HIV antibody
History of regular alcohol consumption within 6 months of the study

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
GSK557296 10 mg10 mg single oral dose. Each subject will receive 2 tablets of 5 mg GSK557296 four times a day (QID).	Drug	Cohort 1: GSK557296 10 mg
GSK557296 150 mg150 mg single oral dose. Each subject will receive multiple tablets of 25 mg GSK557296 either 2, 3 or 4 times a day.	Drug	Cohort 2: GSK557296 150 mg
GSK557296 dose 3Dose to be determined as a single dose tablet based on half-life demonstrated in Cohort 1 and Cohort 2.	Drug	Cohort 3
GSK557296 dose 4Dose to be determined by PK of prior doses, based on half-life demonstrated in prior cohorts.	Drug	Cohort 4

Primary outcome

Composite of PK parameters of 20 mg GSK557296 following single and repeat oral dosing
Time frame: 7 days
From the plasma concentration-time data, the following PK parameters will be determined: maximum observed plasma concentration (Cmax), time to Cmax (tmax), area under the plasma concentration-time curve [AUC(0-t) and AUC(0-infinity)], and apparent terminal phase half-life (t1/2). AUC(0-infinity) or AUC(0-τ) and Cmax following single and repeat doses may be used for assessment of dose proportionality.
Composite of PK parameters of 150 mg GSK557296 following single and repeat oral dosing
Time frame: 14 days
From the plasma concentration-time data, the following PK parameters will be determined: maximum observed plasma concentration (Cmax), time to Cmax (tmax), area under the plasma concentration-time curve [AUC(0-t) and AUC(0-infinity)], and apparent terminal phase half-life (t1/2). AUC(0- infinity) or AUC(0-τ) and Cmax following single and repeat doses may be used for assessment of dose proportionality.
Safety and tolerability of GSK557296 following single and repeat dosing
Time frame: up to 49 days
Safety and tolerability parameters assessments include adverse events, clinical laboratory, ECG, vital signs, and concurrent medication

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 Jun 2017.
Derived from this study: PubMed 27137713Mahar KM, Stier B, Fries M, McCallum SW. A single- and multiple-dose study to investigate the pharmacokinetics of epelsiban and its metabolite, GSK2395448, in healthy female volunteers. Clin Pharmacol Drug Dev. 2015 Nov;4(6):418-26. doi: 10.1002/cpdd.210. Epub 2015 Aug 26.
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
Results for study 116741 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Related trials for Embryo Transfer

Not yet recruiting
Cryopreserved Pre-embryo Transfer in a Cytokine-rich Medium Versus Hyaluronic Acid
Frozen Embryo Transfer (FET)
Active, not recruitingPhase 3
Human Menopausal Gonadotropin Research in Infertility Assessing Cumulative Live Birth With Frozen Embryo Transfer.
Infertility (IVF Patients)
Not yet recruitingObservational study
Linzagolix in Adenomyosis and Recurrent Implantation Failure
Adenomyosis of Uterus, Implantation Failure
RecruitingPhase 2
Effect of FB301 on Vaginal Bacterial Profile in Women With Asymptomatic Vaginal Dysbiosis Undergoing a Mock Frozen Embryo Transfer Cycle
Vaginal Dysbiosis
RecruitingPhase 2/3
Thymosin-α1 for Recurrent Implantation Failure
Recurrent Implantation Faliure

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

GlaxoSmithKline

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 GSK557296 10 mg, GSK557296 150 mg and GSK557296 dose 3 in people with Embryo Transfer, run by GlaxoSmithKline at 1 site in United States.

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 13 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 Jun 2017. 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 States. 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?

Composite of PK parameters of 20 mg GSK557296 following single and repeat oral dosing (time frame: 7 days). The study lists 3 primary outcomes in all. 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 NCT01669083, which also lists 1 linked publication.

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 Jun 2017.