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GSK investigational drug

Phase 1

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment41
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00828867Single Dose Escalation First Time in Human PK StudyPHASE1 COMPLETED 41 — — Nov 14, 2008Dec 7, 2009Jun 20, 20171 Australia
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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)
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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 -
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Eligibility Criteria
Age Range18 Years — 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
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