Tuberculosis
Conditions
Interventions
GSK2556286 Tablets for oral administration are available as white tablets
containing 25 mg, 75 mg, or 250 mg of the drug substance GSK2556286A (free
base).
Sponsors
GlaxoSmithKline
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
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 an EMA-approved COVID-19 vaccine 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 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. Note: Screened participants with laboratory values outside of the normal range may be rescreened once for inclusion into the study at the discretion of the Investigator. Body weight *50kg, and body mass index (BMI) within the range 19 to 29.9 kg/m2 inclusive. Male and/or Female Participants: Male participants: A male participant with a female partner of reproductive potential must agree to use contraception as detailed in Appendix 4 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. Female participants: A female participant is eligible to participate if she is not a woman of childbearing potential (WONCBP) as defined in Appendix 4 of this clinical study protocol. 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, haematological, 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) >1.5xupper limit of normal (ULN) Total bilirubin >1.5xULN (isolated total bilirubin >1.5xULN may be acceptable, after consultation with the GSK Medical Monitor, if total bilirubin is fractionated and direct bilirubin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability of GSK2556286: Number and severity of Serious and Non-Serious Adverse Events. Plasma concentrations of GSK2556286 plus derived parameters, as data allow. For Single Ascending Dose (SAD) part: Derived pharmacokinetic parameters for GSK2556286 including area under the plasma drug concentration versus time curve (AUC(0-t), AUC(0-*), maximum observed plasma drug concentration (Cmax), time to maximum observed plasma drug concentration (tmax) and apparent terminal half-life (t1/2) as data allow. For Multiple Ascending Dose (MAD) part: AUC(0-t), AUC(0-*), AUC(0-*), Cmax, tmax, trough plasma concentration (C*) and t1/2. | — |
Secondary
| Measure | Time frame |
|---|---|
| For SAD part: Derived pharmacokinetic parameters for GSK2556286 following single dose (fasted and fed) including area under the plasma drug concentration versus time curve (AUC(0-t), AUC(0-*), Cmax, tmax, t1/2 as data allow. Dose-proportionality assessment using derived PK parameters, as data allow: For SAD part: AUC(0-*), AUC(0-t), Cmax For MAD part: AUC(0-*), Cmax Observed accumulation ratio based on AUC (Ro) and Cmax (RCmax) and steady-state ratio (Rss) following repeat dosing. Trough plasma concentrations at the end of the dosing interval (C*) to assess the achievement of steady-state of GSK2556286 following repeat oral doses. | — |
Countries
Netherlands
Outcome results
None listed