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TerminatedNCT04472897Updated May 11, 2025

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

A Phase 1 interventional study of GSK2556286 and Placebo in Tuberculosis, sponsored by GlaxoSmithKline. Terminated at 2 sites in 2 countries. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-11.

Sponsored by GlaxoSmithKline · Phase 1, Interventional, and Treatment

Why this study was terminated
A decision to stop the study was made by the site and GSK project team based on pre-defined stopping criteria in the protocol
Phase
Phase 1
Study type
Interventional
Enrollment
92
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study summary

This first time in human (FTIH) study assesses the safety, tolerability, and pharmacokinetics (PK) of single and multiple increasing doses of GSK2556286. It also includes food effect cohorts to evaluate how food influences the PK of GSK2556286. The findings will help determine appropriate dosing for future clinical studies.

02

Conditions studied

  • Tuberculosis

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Keywords

  • GSK2556286
  • Pharmacokinetics
  • Interventional
  • Tuberculosis
  • Placebo-controlled
  • First time in human
03

In context

Tuberculosis

1,417 studies on the registry are indexed under Tuberculosis; 208 are open to participants now.

This study's enrollment of 92 is below the median of 150 across 952 interventional studies indexed under Tuberculosis.

Browse Tuberculosis studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.

Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Participant must be 18 to 60 years of age inclusive, at the time of signing the informed consent. Participants aged 51 to 60 years must have received at least one dose of Coronavirus disease-2019 (COVID-19) vaccine approved by the local regulatory authority at least 3 weeks prior to signing the consent form.
  • 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 considers and documents 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

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) greater than (>)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 percent [%]).
  • 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 \<40 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.
  • Cotinine in urine indicative of smoking or history or regular use of tobacco or nicotine-containing products within 3 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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Double (Participant, Investigator)
Enrollment
92 participants (actual)

Study arms

  • Experimental
    Part A: Participants receiving GSK2556286

    Participants will be randomized to receive GSK2556286 in any of the 11 cohorts. In each dosing cohort, 6 participants will receive a single dose of GSK2556286. Following initial dosing of cohorts in the fasted state, one cohort will investigate the effect of food administration (high fat meal) on safety, tolerability and PK data of GSK2556286. One cohort may also investigate the effects of a moderate fat meal.

    Drug: GSK2556286

  • Placebo comparator
    Part A: Participants receiving placebo

    Participants will be randomized to receive matching placebo in any of the 11 cohorts. In each dosing cohort, 2 participants will receive a single dose of matching placebo.

    Drug: Placebo

  • Experimental
    Part B: Participants receiving GSK2556286

    Participants will be randomized to receive GSK2556286 in any of the 4 cohorts. In each dosing cohort, 6 participants will receive repeat doses of GSK2556286 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.

    Drug: GSK2556286

  • Placebo comparator
    Part B: Participants receiving placebo

    Participants will be randomized to receive matching placebo in any of the 4 cohorts. In each dosing cohort, 2 participants will receive repeat doses of matching placebo under either fasting or fed conditions, dependent on the results from Part A.

    Drug: Placebo

Interventions

  • DrugGSK2556286

    GSK2556286 will be administered.

  • DrugPlacebo

    Placebo will be administered

06

What researchers measure

Primary outcomes

  1. Part A: Number of participants with any serious adverse events (SAEs) and non-SAEs

    Time frame: Up to Day 15

  2. Part B: Number of participants with any SAEs and non-SAEs

    Time frame: Up to Day 28

  3. Part A: Number of participants with AEs (SAEs and non-SAEs) by severity

    Time frame: Up to Day 15

  4. Part B: Number of participants with AEs (SAEs and non-SAEs) by severity

    Time frame: Up to Day 28

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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. Day 12 and 13: Pre-dose

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. Part B: Trough plasma concentration (Ctau) of GSK2556286

    Time frame: Pre-dose on Days 1, 12, 13 and 14

  18. 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

Secondary outcomes

  1. Part A: AUC(0-t) of GSK2556286 under fasted and 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

  2. Part A: AUC(0-inf) of GSK2556286 under fasted and 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

  3. Part A: Cmax of GSK2556286 under fasted and 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

  4. Part A: Tmax of GSK2556286 under fasted and 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

  5. Part A: T1/2 of GSK2556286 under fasted and 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

07

Study locations

2 sites
  • GSK Investigational Site
    Groningen, 9713 AG, Netherlands
  • GSK Investigational Site
    Cambridge, CB2 2GG, United Kingdom
08

References and documents

Publications

  • Nuermberger EL, Martinez-Martinez MS, Sanz O, Urones B, Esquivias J, Soni H, Tasneen R, Tyagi S, Li SY, Converse PJ, Boshoff HI, Robertson GT, Besra GS, Abrahams KA, Upton AM, Mdluli K, Boyle GW, Turner S, Fotouhi N, Cammack NC, Siles JM, Alonso M, Escribano J, Lelievre J, Rullas-Trincado J, Perez-Herran E, Bates RH, Maher-Edwards G, Barros D, Ballell L, Jimenez E. GSK2556286 Is a Novel Antitubercular Drug Candidate Effective In Vivo with the Potential To Shorten Tuberculosis Treatment. Antimicrob Agents Chemother. 2022 Jun 21;66(6):e0013222. doi: 10.1128/aac.00132-22. Epub 2022 May 24. PubMed 35607978 ↗

Individual participant data

Plan to share: Yes — IPD for this study will be made available via the Clinical Study Data Request site.

Supporting information: Study protocol, Sap, Icf, Csr

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 11, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04472897
Lead sponsor
GlaxoSmithKline
Responsible party
Sponsor
First posted
Jul 16, 2020
Start date
Oct 30, 2020
Primary completion
Nov 6, 2024
Completion
Nov 6, 2024
Last update
May 11, 2025

Study contacts

GSK Clinical Trials
study director · GlaxoSmithKline

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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