A Study to Evaluate Safety, Tolerability and Pharmacokinetics of GSK2556286 in Healthy Adult Participants

• ClinicalTrials.gov Identifier: NCT04472897
• Recruitment Status: Recruiting
• First Posted: July 16, 2020
• Last Update Posted: October 12, 2021
• Sponsor: GlaxoSmithKline
• Information provided by (Responsible Party): GlaxoSmithKline

Tracking Information

• First Submitted Date: July 14, 2020
• First Posted Date: July 16, 2020
• Last Update Posted Date: October 12, 2021
• Actual Study Start Date: October 30, 2020
• Estimated Primary Completion Date: June 30, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 14, 2020)

• Part A: Number of participants with any serious adverse events (SAEs) and non-SAEs [ Time Frame: Up to Day 15 ]
  An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations judged by physician, such as important medical events that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in the above. All non-SAEs will be assessed.
• Part B: Number of participants with any SAEs and non-SAEs [ Time Frame: Up to Day 28 ]
  An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations judged by physician, such as important medical events that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in the above. All non-SAEs will be assessed.
• Part A: Number of participants with AEs (SAEs and non-SAEs) by severity [ Time Frame: Up to Day 15 ]
  The Division of Acquired immunodeficiency syndrome [AIDS] (DAIDS) scale provides grading for the severity of adverse events. The grades range from grade 1 to grade 5: Grade 1: mild event, Grade 2: moderate event, Grade 3: severe event, Grade 4: potentially life threatening and Grade 5: death.
• Part B: Number of participants with AEs (SAEs and non-SAEs) by severity [ Time Frame: Up to Day 28 ]
  The DAIDS scale provides grading for the severity of adverse events. The grades range from grade 1 to grade 5: Grade 1: mild event, Grade 2: moderate event, Grade 3: severe event, Grade 4: potentially life threatening and Grade 5: death.
• Part A: Plasma concentrations of GSK2556286 [ Time Frame: Day 1: Pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15, 24, 36, 48 and 72 hours post-dose ]
  Blood samples for PK analysis of GSK2556286 will be collected at the indicated time points.
• Part A: Area under the plasma drug concentration versus time curve from time zero to last time of quantifiable concentration (AUC[0-t]) of GSK2556286 [ Time Frame: Day 1: Pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15, 24, 36, 48 and 72 hours post-dose ]
  Blood samples for PK analysis of GSK2556286 will be collected at the indicated time points.
• Part A: AUC from time zero extrapolated to infinity (AUC[0-inf]) of GSK2556286 [ Time Frame: Day 1: Pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15, 24, 36, 48 and 72 hours post-dose ]
  Blood samples for PK analysis of GSK2556286 will be collected at the indicated time points.
• Part A: Maximum observed plasma drug concentration (Cmax) of GSK2556286 [ Time Frame: Day 1: Pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15, 24, 36, 48 and 72 hours post-dose ]
  Blood samples for PK analysis of GSK2556286 will be collected at the indicated time points.
• Part A: Time to maximum observed plasma drug concentration (Tmax) of GSK2556286 [ Time Frame: Day 1: Pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15, 24, 36, 48 and 72 hours post-dose ]
  Blood samples for PK analysis of GSK2556286 will be collected at the indicated time points.
• Part A: Apparent terminal half-life (T1/2) of GSK2556286 [ Time Frame: Day 1: Pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15, 24, 36, 48 and 72 hours post-dose ]
  Blood samples for PK analysis of GSK2556286 will be collected at the indicated time points.
• Part B: Plasma concentrations of GSK2556286 [ Time Frame: Day 1 and 14: Pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15, 24, 36, 48 and 72 hours post-dose ]
  Blood samples for PK analysis of GSK2556286 will be collected at the indicated time points.
• Part B: AUC(0-t) of GSK2556286 [ Time Frame: Day 1 and 14: Pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15, 24, 36, 48 and 72 hours post-dose ]
  Blood samples for PK analysis of GSK2556286 will be collected at the indicated time points.
• Part B: AUC(0-inf) of GSK2556286 [ Time Frame: Day 1 and 14: Pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15, 24, 36, 48 and 72 hours post-dose ]
  Blood samples for PK analysis of GSK2556286 will be collected at the indicated time points.
• Part B: Area under the plasma drug concentration versus time curve from time zero during a dosage interval of time tau (AUC[0-tau)] of GSK2556286 [ Time Frame: Day 1 and 14: Pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15, 24, 36, 48 and 72 hours post-dose ]
  Blood samples for PK analysis of GSK2556286 will be collected at the indicated time points.
• Part B: Cmax of GSK2556286 [ Time Frame: Day 1 and 14: Pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15, 24, 36, 48 and 72 hours post-dose ]
  Blood samples for PK analysis of GSK2556286 will be collected at the indicated time points.
• Part B: Tmax of GSK2556286 [ Time Frame: Day 1 and 14: Pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15, 24, 36, 48 and 72 hours post-dose ]
  Blood samples for PK analysis of GSK2556286 will be collected at the indicated time points.
• Part B: Trough plasma concentration (Ctau) of GSK2556286 [ Time Frame: Pre-dose on Days 1, 12, 13 and 14 ]
  Blood samples for PK analysis of GSK2556286 will be collected at the indicated time points
• Part B: T1/2 of GSK2556286 [ Time Frame: Day 1 and 14: Pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15, 24, 36, 48 and 72 hours post-dose ]
  Blood samples for PK analysis of GSK2556286 will be collected at the indicated time points

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: July 14, 2020)

• Part A: AUC(0-t) of GSK2556286 under fed conditions [ Time Frame: Day 1: Pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15, 24, 36, 48 and 72 hours post-dose ]
  Blood samples for PK analysis of GSK2556286 will be collected at the indicated time points in Food Effect cohort.
• Part A: AUC(0-inf) of GSK2556286 under fed conditions [ Time Frame: Day 1: Pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15, 24, 36, 48 and 72 hours post-dose ]
  Blood samples for PK analysis of GSK2556286 will be collected at the indicated time points in Food Effect cohort.
• Part A: Cmax of GSK2556286 under fed conditions [ Time Frame: Day 1: Pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15, 24, 36, 48 and 72 hours post-dose ]
  Blood samples for PK analysis of GSK2556286 will be collected at the indicated time points in Food Effect cohort.
• Part A: Tmax of GSK2556286 under fed conditions [ Time Frame: Day 1: Pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15, 24, 36, 48 and 72 hours post-dose ]
  Blood samples for PK analysis of GSK2556286 will be collected at the indicated time points in Food Effect cohort.
• Part A: T1/2 of GSK2556286 under fed conditions [ Time Frame: Day 1: Pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15, 24, 36, 48 and 72 hours post-dose ]
  Blood samples for PK analysis of GSK2556286 will be collected at the indicated time points in Food Effect cohort.
• Part A: Dose proportionality of GSK2556286 based on AUC(0-inf) [ Time Frame: Day 1: Pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15, 24, 36, 48 and 72 hours post-dose ]
  Dose proportionality will be assessed from AUC(0-inf).
• Part A: Dose proportionality of GSK2556286 based on AUC(0-t) [ Time Frame: Day 1: Pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15, 24, 36, 48 and 72 hours post-dose ]
  Dose proportionality will be assessed from AUC(0-t).
• Part A: Dose proportionality of GSK2556286 based on Cmax [ Time Frame: Day 1: Pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15, 24, 36, 48 and 72 hours post-dose ]
  Dose proportionality will be assessed from Cmax.
• Part B: Dose proportionality of GSK2556286 based on AUC(0-tau) [ Time Frame: Day 1 and 14: Pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15, 24, 36, 48 and 72 hours post-dose ]
  Dose proportionality will be assessed from AUC(0-tau).
• Part B: Dose proportionality of GSK2556286 based on Cmax [ Time Frame: Day 1 and 14: Pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15, 24, 36, 48 and 72 hours post-dose ]
  Dose proportionality will be assessed from Cmax.
• Part B: Observed accumulation ratio of GSK2556286 based on AUC (AUC[Ro]) [ Time Frame: Day 1 and 14: Pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15, 24, 36, 48 and 72 hours post-dose ]
  Blood samples for PK analysis of GSK2556286 will be collected at the indicated time points. Accumulation ratio will be calculated using AUC(0- tau) on Day 14 and AUC(0-tau) on Day 1.
• Part B: Observed accumulation ratio of GSK2556286 based on Cmax (RCmax) [ Time Frame: Day 1 and 14: Pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15, 24, 36, 48 and 72 hours post-dose ]
  Blood samples for PK analysis of GSK2556286 will be collected at the indicated time points. RCmax, will be calculated using Cmax on Day 14 and on Day 1.
• Part B: Steady state ratio (Rss) of GSK2556286 [ Time Frame: Day 1 and 14: Pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15, 24, 36, 48 and 72 hours post-dose ]
  Blood samples for PK analysis of GSK2556286 will be collected at the indicated time points. steady state ratio, Rss will be calculated using AUC(0-tau) on Day 14 and AUC(0-inf) on Day 1.
• Part B: Ctau at the end of the dosing interval to assess steady state of GSK2556286 [ Time Frame: Pre-dose on Days 1, 12, 13 and 14 ]
  Blood samples for PK analysis of GSK2556286 will be collected at the indicated time points. Analysis of Ctau will be performed to evaluate achievement of steady state.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study to Evaluate Safety, Tolerability and Pharmacokinetics of GSK2556286 in Healthy Adult Participants
• Official Title: A Randomised, Double Blind (Sponsor Unblinded), Placebo-controlled, First Time in Human Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Repeat Oral Doses and the Food Effect of GSK2556286 in Healthy Adult Participants
• Brief Summary: This is a randomized, double-blind, placebo-controlled, first time in human (FTIH) study to evaluate the safety, tolerability and pharmacokinetics (PK) of single and repeat ascending doses of GSK2556286 following oral administration in healthy adult participants. A food effect (FE) cohort will investigate the influence of food on the PK of GSK2556286. The study will be conducted in two parts. Part A will be a single ascending dose (SAD), sequential, parallel cohort design including up to 8 cohorts (Cohort 1A to cohort 8A) and Part B will be a multiple ascending dose (MAD), sequential, parallel dose cohort design including up to 4 cohorts (Cohort 1B to cohort 4B). In each cohort of Part A and Part B, participants will be randomized to receive single and repeated oral doses, respectively, of either GSK2556286 or matching placebo, administered in a 3:1 ratio according to the randomization schedule in a blinded manner. In Part A, Cohort 1A till cohort 6A will be dosed under fasted conditions and Cohort 7A and cohort 8A will be dosed under fed conditions. Cohort 7A will investigate the effect of food administration (high fat meal) on safety, tolerability and PK after a single dose of GSK2556286. Based on emerging data, a second food effect cohort (Cohort 8A) may also be included using a higher dose of GSK2556286. Progression from Part A to Part B will be based on an acceptable safety, tolerability and PK profile in Part A. In Part B, participants in each cohort will receive a daily oral dose of GSK2556286 over a period of up to 14 days. Part B may include drug administration after either fed or fasted conditions, dependent on the results from Part A. Sentinel dosing will be used in each cohort in Part A and Part B. Participants can only take part in one dose cohort in either Part A or B of the study.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1

Study Design

Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description:

This is a double-blind, randomized, sequential, parallel dose cohort study.

Masking: Double (Participant, Investigator)
Masking Description:

This is a double-blind study.

Primary Purpose: Treatment

• Condition: Tuberculosis

Intervention

• Drug: GSK2556286
  GSK2556286 is a tablet available in 25 mg, 75 mg and 250 mg dosing strength. It will be given via oral route.
• Drug: Placebo
  Placebo tablet matching to the study treatment will be given via oral route.

Study Arms

• Experimental: Part A: Participants receiving GSK2556286
  Participants will be randomized to receive one of the ascending doses of GSK2556286 in any of the 8 cohorts (Cohort 1A to 8A). In each dosing cohort, 6 participants will receive a single oral dose of GSK2556286 on Day 1 under fasting conditions (Cohort 1A to 6A) and under fed conditions (Cohort 7A and 8A). The starting dose in Part A will be 25 milligrams (mg) and no dose escalation to the next dose will be higher than 3-folds. One cohort (Cohort 7A) will investigate the effect of food administration (high fat meal) on safety, tolerability and PK after a single dose of GSK2556286. Based on emerging data, a second food effect cohort (Cohort 8A) may also be included using a higher dose of GSK2556286.
  Intervention: Drug: GSK2556286
• Placebo Comparator: Part A: Participants receiving placebo
  Participants will be randomized to receive matching placebo in any of the 8 cohorts (Cohort 1A to 8A). In each dosing cohort, 2 participants will receive a single oral dose of matching placebo on Day 1 under fasting conditions (Cohort 1A to 6A) and under fed conditions (Cohort 7A and 8A).
  Intervention: Drug: Placebo
• Experimental: Part B: Participants receiving GSK2556286
  Participants will be randomized to receive one of the multiple-ascending doses of GSK2556286 in any of the 4 cohorts (Cohort 1B to 4B). In each dosing cohort, 6 participants will receive a single oral dose of GSK2556286 on Day 1 up to 14 days under either fasting or fed conditions, dependent on the results from Part A. Appropriate doses and dose regimens for Part B will be selected by the Dose Escalation Committee based on available safety, tolerability and PK data from Part A and/or any preceding repeat dose cohorts from Part B.
  Intervention: Drug: GSK2556286
• Placebo Comparator: Part B: Participants receiving placebo
  Participants will be randomized to receive matching placebo in any of the 4 cohorts (Cohort 1B to 4B). In each dosing cohort, 2 participants will receive a single oral dose of matching placebo on Day 1 up to 14 days under either fasting or fed conditions, dependent on the results from Part A.
  Intervention: Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: July 14, 2020): 96
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: June 30, 2023
• Estimated Primary Completion Date: June 30, 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion criteria:

• Participant must be 18 to 50 years of age inclusive, at the time of signing the informed consent.
• Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring. A participant with a clinical abnormality or laboratory parameter(s) which is/are not specifically listed in the inclusion or exclusion criteria, outside the normal reference range for the population being studied may be included only if the Investigator in consultation with the Medical Monitor (if required) agree and document that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
• Body weight more than or equal to (>=)50 kilograms (kg) and body mass index (BMI) within the range 19 to 29.9 kilograms per meter square (kg/m^2) inclusive.
• Male and/or Female Participants. A male participant with a female partner of reproductive potential must agree to use contraception of this clinical study protocol during the treatment period and for at least 90 days after the last dose of study treatment and refrain from donating sperm during this period. A female participant is eligible to participate if she is not a woman of childbearing potential (WONCBP).
• The participant is able to understand and comply with protocol requirements, instructions and protocol-stated restrictions.

Exclusion criteria:

• Significant history of or current, cardiovascular, respiratory (including asthma), hepatic, renal, gastrointestinal, endocrine, hematological, infectious or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs: constituting a risk when taking part in the study or interfering with the interpretation of data.
• Alanine aminotransferase (ALT) >1.5 times upper limit of normal (ULN).
• Total bilirubin >1.5 times ULN (isolated total bilirubin >1.5 times ULN may be acceptable, after consultation with the GlaxoSmithKline (GSK) Medical Monitor, if total bilirubin is fractionated and direct bilirubin less than [<]35 percentage [%]).
• Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones) or cholecystectomy.
• Current or past history of significant renal disease including renal stones.
• Current or past history of gastroduodenal ulcers or persistent gastritis requiring medication.
• Medical history of cardiac arrhythmias or cardiac disease or a family or personal history of long QT syndrome.

• Exclusion criteria for screening electrocardiogram (ECG) with:

  1. Heart rate of <45 or >100 beats per minute (bpm) in males and <50 or >100 bpm in females.
  2. PR interval of <120 or >220 milliseconds (msec) in males and females.
  3. QRS duration of <70 or >120 msec in males and females.
  4. Electrocardiogram QT interval corrected for heart rate using Fridericia's formula (QTcF) interval of >450 msec in males and females.
• Evidence of previous myocardial infarction (does not include ST segment changes associated with re-polarization).
• Any clinically significant conduction abnormality (including but not specific to left or right complete bundle branch block, atrioventricular [AV] block [second degree or higher], Wolff -Parkinson-White [WPW] syndrome).
• Sinus Pauses >3 seconds.
• Any significant arrhythmia which, in the opinion of the Investigator or GSK Medical monitor, will interfere with the safety for the individual participant.
• Non-sustained or sustained ventricular tachycardia (3 consecutive ventricular ectopic beats).

• Evidence of latent tuberculosis documented by:

  1. medical history and examination.
  2. Tuberculosis (TB) testing : either a positive tuberculin skin test (TST) (defined as a skin induration >5 millimeters [mm] at 48 to 72 hours, regardless of Bacillus Calmette-Guerin (BCG) or other vaccination history) or a positive (not indeterminate) TB test such as QuantiFERON-TB Gold Plus test. In cases where the QuantiFERON or TST is indeterminate, the participant may have the test repeated once, but they will not be eligible for the study unless the second test is negative. In cases where the QuantiFERON or TST test is positive, the participant should be followed up as per standard of care.
• Use of prescription or non-prescription drugs, including Nonsteroidal anti-inflammatory drugs (NSAIDs), high-dose 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 sponsor the medication will not interfere with the study procedures or compromise participant safety. Vitamin C supplementation is prohibited as it may cause crystalluria.
• Cotinine in urine indicative of smoking or history or regular use of tobacco or nicotine-containing products within 6 months.
• Current regular alcohol consumption defined as an average weekly intake of >21 units for males or >14 units for females. One unit is equivalent to 8 grams (g) of alcohol: a half-pint (approximately 240 milliliters [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 Medical Monitor, contraindicates their participation.
• Presence of hepatitis B surface antigen (HBsAg), positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study treatment.
• A positive test for Human immunodeficiency virus (HIV) antibody.
• Urinary analysis indicating presence of blood, protein or glucose. If trace or 1 plus (+) is found on urine dipstick, a repeat test can be performed. If repeat is positive, participant is excluded from recruitment.
• Screening age-appropriate estimated glomerular filtration rate (eGFR) <90 milliliters per minute mL/min as assessed by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.
• Serum (and in the MAD, urinary) electrolytes outside of normal range. May be repeated once if abnormal.
• A positive pre-study drug/alcohol screen.
• The participant has taken part 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: 90 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.
• Part A (Food Effect) Cohort: Participant must have no relevant dietary restrictions (lactose intolerance) or inability to eat a high fat meal.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 50 Years (Adult)
• Accepts Healthy Volunteers: Yes

Contacts

Contact: US GSK Clinical Trials Call Center; 877-379-3718; GSKClinicalSupportHD@gsk.com

Contact: EU GSK Clinical Trials Call Center; +44 (0) 20 89904466; GSKClinicalSupportHD@gsk.com

• Listed Location Countries: Netherlands

Administrative Information

• NCT Number: NCT04472897
• Other Study ID Numbers: 210035
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: IPD for this study will be made available via the Clinical Study Data Request site.
• Supporting Materials: Study Protocol
• Supporting Materials: Statistical Analysis Plan (SAP)
• Supporting Materials: Informed Consent Form (ICF)
• Supporting Materials: Clinical Study Report (CSR)
• Time Frame: IPD will be made available within 6 months of publishing the results of the primary endpoints of the study.
• Access Criteria: Access is provided after a research proposal is submitted and has received approval from the 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 can be granted, when justified, for up to another 12 months.
• URL: http://clinicalstudydatarequest.com

• Responsible Party: GlaxoSmithKline
• Study Sponsor: GlaxoSmithKline
• Collaborators: Not Provided

Investigators

• Study Director: GSK Clinical Trials; GlaxoSmithKline

• PRS Account: GlaxoSmithKline
• Verification Date: October 2021