Embryo TransferPhase 1NCT02703181

Dose Escalation Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Epelsiban Administered in Repeat Doses in Healthy Women Volunteers

A Phase 1 study testing Epelsiban (GSK557296) 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

The current study is designed to assess the safety, tolerability and pharmacokinetics (PK) of additional repeat doses of epelsiban in healthy females, and will be the first dosing experience of repeat dosing at higher doses in women with this compound. Read more about this study

Who is it for?: Ages 18 to 55 years, women onlyHealthy volunteers can take part
Conditions the study is for: Embryo Transfer
What is being tested?: Epelsiban (GSK557296)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 31 participants
Where: 1 siteUnited States
Study dates: 9 Jul 2015to 10 Sep 2015
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 55 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

Female between 18 and 55 years of age inclusive, at the time of consent
Healthy as determined by the investigator or medically qualified designee based on a medical evaluation including medical history, review of medications previously used, physical examination, laboratory tests and electrocardiogram (ECG).
Body mass index (BMI) within the range 18 - 35 kilogram per squared meter (kg/m^2) (inclusive)
Not pregnant (as confirmed by a negative serum human chorionic gonadotropin [hCG] test), not lactating, and at least one of the following conditions applies: Non-reproductive potential defined as: Pre-menopausal females, postmenopausal, or women of reproductive potential who agree to follow one of the options listed in the GlaxoSmithKline (GSK) Modified List of Highly Effective Methods for Avoiding Pregnancy in Females of Reproductive Potential.

Who cannot join

History of clinically significant abnormal transvaginal ultrasound
Alanine aminotransferase (ALT) and bilirubin >1.5 x upper limit of normal (ULN) (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
Corrected QT interval (QTc) > 450 milliseconds (msec)
History of regular alcohol consumption within three months of dosing on Day 1 defined as: an average weekly intake of >7 drinks. One drink is equivalent to 12 gram (g) of alcohol: 12 ounces (360 milliliters [mL]) of beer, 5 ounces (150 mL) of wine or 1.5 ounces (45 mL) of 80 proof distilled spirits.
Urinary cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products within three months prior to screening.

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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.
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 known to inhibit or induce Cytochrome P450 3A4 [P450 CYP3A4]) 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.
Presence of hepatitis B surface antigen (HBsAg), positive hepatitis C antibody test result at screening or within three months prior to first dose of study treatment.
A positive pre-study drug/alcohol screen.
A positive test for human immunodeficiency virus (HIV) antibody.
Where participation in the study would result in donation of blood or blood products in excess of 500 mL within three months
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.

Trial locations and contacts

1 site in 1 country.

United States1 site

GSK Investigational Site
Overland Park, Kansas, 66211

Other trials in United States

About this study

Official title: A Randomized, Placebo-controlled, Double-Blind (Sponsor Unblind), Repeat Dose, Ascending Cohort, Dose Escalation Phase I Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Epelsiban and Its Major Metabolite in Healthy Women Volunteers Following Administration of Repeat Dosing of Epelsiban

This study is a 14 day, randomized, placebo-controlled, double blind (sponsor unblind), repeat dose, ascending cohort, dose escalation study in healthy, female volunteers. Upon successful completion of the Screening period, a subject will be enrolled in the study. The study will be composed of three periods: Screening, Treatment and Follow-up. A subject's total time involved in the study will be approximately six weeks.

Cohorts will be conducted sequentially. Each subject will be enrolled in only one cohort. Ten subjects will be enrolled in each cohort and randomized to epelsiban (n=8) or placebo (n=2).

Conditions: Embryo Transfer
Being tested: Epelsiban (GSK557296), Placebo to match GSK557296
Keywords: Safety, Dose Escalation, Repeat Dosing, Epelsiban, Pharmacokinetics, Healthy Women Volunteers, Tolerability, Oxytocin

What participants receive

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

Epelsiban (GSK557296)Drug
White to off-white 0.270 inches x 0.700 inches oblong film coated tablet containing 25 mg or 100 mg epelsiban. To be swallowed whole with water, not to be chewed.
Placebo to match GSK557296Drug
White to off-white 0.270 inches x 0.700 inches oblong film coated Tablet containing placebo. To be swallowed whole with water, not to be chewed.

Study groups in NCT02703181
Study group	Role	What they receive
Cohort 1(600 mg Epelsiban or placebo[every 8 hours])	Experimental	Each subject will receive 200 mg of epelsiban administered TID (every 8 hours) (total daily dose of 600 mg) or a matching placebo administered every 8 hours. Receives: Drug: Epelsiban (GSK557296); Drug: Placebo to match GSK557296

What is being measured

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

Area under the concentration versus time from time zero to infinite time (AUC[0 to infinity]) for epelsiban and GSK2395448
Blood samples were collected for Cohort 1 and 2 on Days 1, 7, and 14 at Pre-dose ante meridiem (AM), Pre Dose post meridiem (PM), Pre- Dose PM2 (second PM dose [16h]), 0.5, 1, 2, 6, 8.5, 10, 14, 16.5, 17 and 24 hours post dose. Blood samples were collected for Cohort 3 on Days 1, 7, and 14 at Pre-dose AM, Pre Dose PM, 0.5, 1, 4, 6, 8, 12.5, 13, 16 and 24 hours post dose.
Measured: Up to Day 15 (Day 1, 7 and 14)
Area under the concentration versus time from time zero to last time point with measurable concentration (AUC [0-t]) for epelsiban and GSK2395448
Blood samples were collected for Cohort 1 and 2 on Days 1, 7, and 14 at Pre-dose AM, Pre Dose PM, Pre- Dose PM2 (second PM dose [16h]), 0.5, 1, 2, 6, 8.5, 10, 14, 16.5, 17 and 24 hours post dose. Blood samples were collected for Cohort 3 on Days 1, 7, and 14 at Pre-dose AM, Pre Dose PM, 0.5, 1, 4, 6, 8, 12.5, 13, 16 and 24 hours post dose.
Measured: Up to Day 15 (Day 1, 7 and 14)
Area under the concentration-time curve over the dosing interval (AUC [0-tau]) for epelsiban and GSK2395448
Blood samples were collected for Cohort 1 and 2 on Days 1, 7, and 14 at Pre-dose AM, Pre Dose PM, Pre- Dose PM2 (second PM dose [16h]), 0.5, 1, 2, 6, 8.5, 10, 14, 16.5, 17 and 24 hours post dose. Blood samples were collected for Cohort 3 on Days 1, 7, and 14 at Pre-dose AM, Pre Dose PM, 0.5, 1, 4, 6, 8, 12.5, 13, 16 and 24 hours post dose.
Measured: Up to Day 15 (Day 1, 7 and 14)
Maximum observed concentration (Cmax) for epelsiban and GSK2395448
Blood samples were collected for Cohort 1 and 2 on Days 1, 7, and 14 at Pre-dose AM, Pre Dose PM, Pre- Dose PM2 (second PM dose [16h]), 0.5, 1, 2, 6, 8.5, 10, 14, 16.5, 17 and 24 hours post dose. Blood samples were collected for Cohort 3 on Days 1, 7, and 14 at Pre-dose AM, Pre Dose PM, 0.5, 1, 4, 6, 8, 12.5, 13, 16 and 24 hours post dose.
Measured: Up to Day 15 (Day 1, 7 and 14)
Time of occurrence of Cmax (tmax) for epelsiban and GSK2395448
Blood samples were collected for Cohort 1 and 2 on Days 1, 7, and 14 at Pre-dose AM, Pre Dose PM, Pre- Dose PM2 (second PM dose [16h]), 0.5, 1, 2, 6, 8.5, 10, 14, 16.5, 17 and 24 hours post dose. Blood samples were collected for Cohort 3 on Days 1, 7, and 14 at Pre-dose AM, Pre Dose PM, 0.5, 1, 4, 6, 8, 12.5, 13, 16 and 24 hours post dose.
Measured: Up to Day 15 (Day 1, 7 and 14)
Terminal phase half-life (t1/2) for epelsiban and GSK2395448
Blood samples were collected for Cohort 1 and 2 on Days 1, 7, and 14 at Pre-dose AM, Pre Dose PM, Pre- Dose PM2 (second PM dose [16h]), 0.5, 1, 2, 6, 8.5, 10, 14, 16.5, 17 and 24 hours post dose. Blood samples were collected for Cohort 3 on Days 1, 7, and 14 at Pre-dose AM, Pre Dose PM, 0.5, 1, 4, 6, 8, 12.5, 13, 16 and 24 hours post dose.
Measured: Up to Day 15 (Day 1, 7 and 14)
Safety as assessed by the number of subjects with adverse events (AE) and serious adverse events (SAE)
An AE is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Measured: Up to Day 25
Number of Subjects with clinically-significant changes in physical examination findings
A complete physical examination will include, at a minimum, assessment of the cardiovascular (CV), respiratory, gastrointestinal and neurological systems. Weight will also be measured and recorded; height will only be measured and recorded at Screening.
Measured: Up to Day 25
Number of Subjects with clinically-significant changes in electrocardiograms (ECG)
12-lead ECGs will be obtained after the subject has rested in the semi-supine position for at least 15 minutes. Triplicate 12-lead ECGs will be obtained at each time point during the study using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and corrected QT (QTc) intervals.
Measured: Up to Day 15
Blood pressure (BP) as a measure of safety and tolerability
Triplicate readings of systolic and diastolic blood pressure will be obtained at each time point in semi-supine position after five minutes of rest.
Measured: Up to Day 15
Pulse rate measurements as a measure of safety and tolerability
Triplicate readings of pulse rate will be obtained at each time point in semi-supine position after five minutes of rest.
Measured: Up to Day 15
Number of subjects with abnormal laboratory parameters
Clinical laboratory assessments will include hematology, clinical chemistry and urinalysis.
Measured: Up to Day 15

Timeline

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

9 Jul 201510 Sep 2015

First posted9 Mar 2016 (estimated)
Study start9 Jul 2015
Primary completion10 Sep 2015
Study completion10 Sep 2015

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: Randomised
Intervention model: Single group
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 31 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02703181
Sponsor's protocol ID: 201752
Status last verified: Sep 2018
First submitted: 17 Jun 2015
Last updated: 13 Sep 2018
Results posted: No
Data monitoring committee: No
Individual data sharing: Yes: IPD for this study will be made available via the Clinical Study Data Request site.

Publications

Mahar KM, Enslin MB, Gress A, Amrine-Madsen H, Cooper M. Single- and Multiple-Day Dosing Studies to Investigate High-Dose Pharmacokinetics of Epelsiban and Its Metabolite, GSK2395448, in Healthy Female Volunteers. Clin Pharmacol Drug Dev. 2018 Jan;7(1):33-43. doi: 10.1002/cpdd.363. Epub 2017 May 26.
PubMed 28556598

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 13 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Placebo-controlled, Double-Blind (Sponsor Unblind), Repeat Dose, Ascending Cohort, Dose Escalation Phase I Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Epelsiban and Its Major Metabolite in Healthy Women Volunteers Following Administration of Repeat Dosing of Epelsiban
ClinicalTrials.gov ID: NCT02703181
Acronym / sponsor ID: 201752
Conditions: Embryo Transfer
Keywords: Safety, Dose Escalation, Repeat Dosing, Epelsiban, Pharmacokinetics, Healthy Women Volunteers, Tolerability, Oxytocin
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 31 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 9 Jul 2015 (actual)
Primary completion: 10 Sep 2015 (actual)
Study completion: 10 Sep 2015 (actual)
First posted: 9 Mar 2016 (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.

Cohorts will be conducted sequentially. Each subject will be enrolled in only one cohort. Ten subjects will be enrolled in each cohort and randomized to epelsiban (n=8) or placebo (n=2).

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 1

Arm	Type	Receives
Cohort 1(600 mg Epelsiban or placebo[every 8 hours])	Experimental	Drug: Epelsiban (GSK557296), Drug: Placebo to match GSK557296Each subject will receive 200 mg of epelsiban administered TID (every 8 hours) (total daily dose of 600 mg) or a matching placebo administered every 8 hours.

Who may qualify

Ages: 18 to 55 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Female between 18 and 55 years of age inclusive, at the time of consent
Healthy as determined by the investigator or medically qualified designee based on a medical evaluation including medical history, review of medications previously used, physical examination, laboratory tests and electrocardiogram (ECG).
Body mass index (BMI) within the range 18 - 35 kilogram per squared meter (kg/m^2) (inclusive)
Not pregnant (as confirmed by a negative serum human chorionic gonadotropin [hCG] test), not lactating, and at least one of the following conditions applies: Non-reproductive potential defined as: Pre-menopausal females, postmenopausal, or women of reproductive potential who agree to follow one of the options listed in the GlaxoSmithKline (GSK) Modified List of Highly Effective Methods for Avoiding Pregnancy in Females of Reproductive Potential.

Key exclusion criteria (14 listed)

History of clinically significant abnormal transvaginal ultrasound
Alanine aminotransferase (ALT) and bilirubin >1.5 x upper limit of normal (ULN) (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
Corrected QT interval (QTc) > 450 milliseconds (msec)
History of regular alcohol consumption within three months of dosing on Day 1 defined as: an average weekly intake of >7 drinks. One drink is equivalent to 12 gram (g) of alcohol: 12 ounces (360 milliliters [mL]) of beer, 5 ounces (150 mL) of wine or 1.5 ounces (45 mL) of 80 proof distilled spirits.

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
Epelsiban (GSK557296)White to off-white 0.270 inches x 0.700 inches oblong film coated tablet containing 25 mg or 100 mg epelsiban. To be swallowed whole with water, not to be chewed.	Drug	Cohort 1(600 mg Epelsiban or placebo[every 8 hours])
Placebo to match GSK557296White to off-white 0.270 inches x 0.700 inches oblong film coated Tablet containing placebo. To be swallowed whole with water, not to be chewed.	Drug	Cohort 1(600 mg Epelsiban or placebo[every 8 hours])

Primary outcome

Area under the concentration versus time from time zero to infinite time (AUC[0 to infinity]) for epelsiban and GSK2395448
Time frame: Up to Day 15 (Day 1, 7 and 14)
Blood samples were collected for Cohort 1 and 2 on Days 1, 7, and 14 at Pre-dose ante meridiem (AM), Pre Dose post meridiem (PM), Pre- Dose PM2 (second PM dose [16h]), 0.5, 1, 2, 6, 8.5, 10, 14, 16.5, 17 and 24 hours post dose. Blood samples were collected for Cohort 3 on Days 1, 7, and 14 at Pre-dose AM, Pre Dose PM, 0.5, 1, 4, 6, 8, 12.5, 13, 16 and 24 hours post dose.
Area under the concentration versus time from time zero to last time point with measurable concentration (AUC [0-t]) for epelsiban and GSK2395448
Time frame: Up to Day 15 (Day 1, 7 and 14)
Blood samples were collected for Cohort 1 and 2 on Days 1, 7, and 14 at Pre-dose AM, Pre Dose PM, Pre- Dose PM2 (second PM dose [16h]), 0.5, 1, 2, 6, 8.5, 10, 14, 16.5, 17 and 24 hours post dose. Blood samples were collected for Cohort 3 on Days 1, 7, and 14 at Pre-dose AM, Pre Dose PM, 0.5, 1, 4, 6, 8, 12.5, 13, 16 and 24 hours post dose.
Area under the concentration-time curve over the dosing interval (AUC [0-tau]) for epelsiban and GSK2395448
Time frame: Up to Day 15 (Day 1, 7 and 14)
Blood samples were collected for Cohort 1 and 2 on Days 1, 7, and 14 at Pre-dose AM, Pre Dose PM, Pre- Dose PM2 (second PM dose [16h]), 0.5, 1, 2, 6, 8.5, 10, 14, 16.5, 17 and 24 hours post dose. Blood samples were collected for Cohort 3 on Days 1, 7, and 14 at Pre-dose AM, Pre Dose PM, 0.5, 1, 4, 6, 8, 12.5, 13, 16 and 24 hours post dose.
Maximum observed concentration (Cmax) for epelsiban and GSK2395448
Time frame: Up to Day 15 (Day 1, 7 and 14)
Blood samples were collected for Cohort 1 and 2 on Days 1, 7, and 14 at Pre-dose AM, Pre Dose PM, Pre- Dose PM2 (second PM dose [16h]), 0.5, 1, 2, 6, 8.5, 10, 14, 16.5, 17 and 24 hours post dose. Blood samples were collected for Cohort 3 on Days 1, 7, and 14 at Pre-dose AM, Pre Dose PM, 0.5, 1, 4, 6, 8, 12.5, 13, 16 and 24 hours post dose.
Time of occurrence of Cmax (tmax) for epelsiban and GSK2395448
Time frame: Up to Day 15 (Day 1, 7 and 14)
Blood samples were collected for Cohort 1 and 2 on Days 1, 7, and 14 at Pre-dose AM, Pre Dose PM, Pre- Dose PM2 (second PM dose [16h]), 0.5, 1, 2, 6, 8.5, 10, 14, 16.5, 17 and 24 hours post dose. Blood samples were collected for Cohort 3 on Days 1, 7, and 14 at Pre-dose AM, Pre Dose PM, 0.5, 1, 4, 6, 8, 12.5, 13, 16 and 24 hours post dose.
Terminal phase half-life (t1/2) for epelsiban and GSK2395448
Time frame: Up to Day 15 (Day 1, 7 and 14)
Blood samples were collected for Cohort 1 and 2 on Days 1, 7, and 14 at Pre-dose AM, Pre Dose PM, Pre- Dose PM2 (second PM dose [16h]), 0.5, 1, 2, 6, 8.5, 10, 14, 16.5, 17 and 24 hours post dose. Blood samples were collected for Cohort 3 on Days 1, 7, and 14 at Pre-dose AM, Pre Dose PM, 0.5, 1, 4, 6, 8, 12.5, 13, 16 and 24 hours post dose.
Safety as assessed by the number of subjects with adverse events (AE) and serious adverse events (SAE)
Time frame: Up to Day 25
An AE is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Number of Subjects with clinically-significant changes in physical examination findings
Time frame: Up to Day 25
A complete physical examination will include, at a minimum, assessment of the cardiovascular (CV), respiratory, gastrointestinal and neurological systems. Weight will also be measured and recorded; height will only be measured and recorded at Screening.
Number of Subjects with clinically-significant changes in electrocardiograms (ECG)
Time frame: Up to Day 15
12-lead ECGs will be obtained after the subject has rested in the semi-supine position for at least 15 minutes. Triplicate 12-lead ECGs will be obtained at each time point during the study using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and corrected QT (QTc) intervals.
Blood pressure (BP) as a measure of safety and tolerability
Time frame: Up to Day 15
Triplicate readings of systolic and diastolic blood pressure will be obtained at each time point in semi-supine position after five minutes of rest.
Pulse rate measurements as a measure of safety and tolerability
Time frame: Up to Day 15
Triplicate readings of pulse rate will be obtained at each time point in semi-supine position after five minutes of rest.
Number of subjects with abnormal laboratory parameters
Time frame: Up to Day 15
Clinical laboratory assessments will include hematology, clinical chemistry and urinalysis.

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 13 Sep 2018.
Derived from this study: PubMed 28556598Mahar KM, Enslin MB, Gress A, Amrine-Madsen H, Cooper M. Single- and Multiple-Day Dosing Studies to Investigate High-Dose Pharmacokinetics of Epelsiban and Its Metabolite, GSK2395448, in Healthy Female Volunteers. Clin Pharmacol Drug Dev. 2018 Jan;7(1):33-43. doi: 10.1002/cpdd.363. Epub 2017 May 26.
Results for study 201752 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
Individual participant dataSharing planned: Yes. IPD for this study will be made available via the Clinical Study Data Request site.

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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

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 Epelsiban (GSK557296) 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 4 inclusion and 14 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 13 Sep 2018. 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?

Area under the concentration versus time from time zero to infinite time (AUC[0 to infinity]) for epelsiban and GSK2395448 (time frame: Up to Day 15 (Day 1, 7 and 14)). The study lists 12 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 NCT02703181, 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 13 Sep 2018.