Recent Updates
Recently added Catalysts

GSK investigational drug

Phase 1

Infections, Bacterial | Small molecule | Infectious Disease |GSK plc|Last Updated: Jun 20, 2017

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment41

FDA Designations

No designations recorded

Clinical trial landscape

GSK investigational drug · 1 trial · 1 indication

Phase 1 1
NCT00828867Single Dose Escalation First Time in Human PK StudyInfections, Bacterial
COMPLETED41 Analytics
PHASE1COMPLETED
Single Dose Escalation First Time in Human PK Study
Infections, Bacterial
NCT0082886741
Unlock trial analytics

Study Endpoints

Primary Endpoints

Safety parameters, adverse events, absolute values and changes over time of hematology, clinical chemistry, urinalysis, vital signs, electrocardiogram intervals, and ECG rhythm.
Eighteen days
Pharmacokinetic parameters following single dose administration: area under the plasma concentration curve AUC 0 to inf, AUC 0 to t, AUC 0 to 24, maximum observed concentration , time to maximum observed concentration , terminal half life .
Two days, Three days (3000mg and 4000mg only)

Secondary Endpoints

AUC 0 to inf and Cmax following single dose administration for the assessment of dose proportionality
Two days, Three days (3000mg and 4000mg only)
Amount excreted of unchanged study drug and renal clearance
Two days, Three days (3000mg and 4000mg only)
AUC 0 to inf, AUC 0 to t, AUC 0 to 24, Cmax, tmax and tlag if deemed appropriate with and without high fat calorie meal
Two days, Three days (3000mg and 4000mg only)
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Cohort 1EXPERIMENTAL100mg
Cohort 2EXPERIMENTAL200mg
Cohort 3EXPERIMENTAL400mg
Cohort 4EXPERIMENTAL800mg
Cohort 5EXPERIMENTAL1500mg
Cohort 6EXPERIMENTAL2000mg
Cohort 7EXPERIMENTAL800mg with food
Cohort 8EXPERIMENTAL3000mg
Cohort 9EXPERIMENTAL4000mg

Interventions

NameTypeDescription
100 mg GSK investigational drugDRUG -
200 mg GSK investigational drugDRUG -
400 mg GSK investigational drugDRUG -
800 mg GSK investigational drugDRUG -
2000 mg GSK investigational drugDRUG -
1500 mg GSK investigational drugDRUG -
800mg fed GSK investigational drugDRUG -
3000mg GSK investigational drugDRUG -
4000mg GSK investigational drugDRUG -
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy * male * non-childbearling potential females * Body weight greater than or equal to 50 kg (110 lbs) for men and greater than or equal to 45 kg (99 lbs) for women. Body mass index (BMI) between 18.5-29.9 kg/m2 inclusive. * Capable of giving written informed consent, whi...

Countries:Australia
Unlock Eligibility Criteria

Frequently asked questions about GSK investigational drug

What is GSK investigational drug used for?

GSK investigational drug is a small molecule being developed for the treatment of bacterial infections. It is currently in Phase 1 clinical development, with one completed trial that enrolled 41 participants. The drug is being studied as a potential therapeutic option for infections caused by bacteria.

Who makes GSK investigational drug?

GSK investigational drug is being developed by GSK plc, a global biopharmaceutical company listed on the stock exchange under the ticker GSK. The company is conducting clinical research to evaluate the safety and efficacy of this small molecule for bacterial infections.

What phase is GSK investigational drug in?

GSK investigational drug is in Phase 1 clinical development. The Phase 1 trial, which was a single dose escalation first time in human pharmacokinetic study, has been completed. The drug is still investigational and has not yet been approved for any use.

What clinical trials is GSK investigational drug in?

GSK investigational drug has one completed clinical trial registered under NCT00828867, titled 'Single Dose Escalation First Time in Human PK Study'. This Phase 1 trial enrolled 41 participants in Australia, including healthy volunteers aged 18 years and older. The study was randomized, double-blind, and controlled.

Is GSK investigational drug FDA approved?

GSK investigational drug is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The completed Phase 1 trial was designed to evaluate safety and pharmacokinetics, but the drug has not yet received regulatory approval for the treatment of bacterial infections.