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GSK1322888

Phase 1

Gastroparesis | Small molecule | Gastrointestinal |GSK plc|Last Updated: Jun 28, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment17

FDA Designations

No designations recorded

Clinical trial landscape

GSK1322888 · 1 trial · 1 indication

Phase 1 1
NCT01294566FTIH to Evaluate Safety, Tolerability, and Pharmacokinetics of Single Oral Doses of GSK1322888 in Healthy Caucasian and Japanese VolunteersGastroparesis
COMPLETED17 Analytics
PHASE1COMPLETED
FTIH to Evaluate Safety, Tolerability, and Pharmacokinetics of Single Oral Doses of GSK1322888 in Healthy Caucasian and Japanese Volunteers
GastroparesisUnlock trial analytics

Study Endpoints

Primary Endpoints

Adverse Events following single oral doses of GSK1322888
1 week post dose

includes abnormal clincal lab values, ECGs, vital signs

pharmacokinetics of GSK1322888 following single, oral doses
48 h post dose

includes AUC, Cmax, tmax, and t1/2

Secondary Endpoints

gastric emptying of a radio-labeled test meal, as measured by the 13C-octanoic acid breath test following single oral doses of GSK1322888
4 h
dose/exposure response relationship for gastric emptying of a radio-labeled test meal, as measured by the 13C-octanoic acid breath test following single oral doses of GSK1322888
48 h
dose proportionality following single dose administration
48 h
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Cohort 1EXPERIMENTALGSK1322888 (1 mg, 2 mg, 5 mg, 10 mg; 6 subjects) and Placebo (32 subjects)
Cohort 2EXPERIMENTALGSK1322888 (20 mg, 40 mg, 80 mg, and dose to be determined; 6 subjects) and Placebot (2 subjects)

Interventions

NameTypeDescription
GSK1322888DRUG1 mg, 5 mg or 25 mg capsule
PlaceboDRUGmatching placebo capsules
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * AST, ALT, alkaline phosphatase and bilirubin \< or =1.5xULN (isolated bilirubin \>1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin \<35%). * Healthy as determined by a responsible and experienced physician * Male or female between 18 (20 for Japanese) an...

Countries:Australia
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Competitive Landscape -Gastroparesis 2 trials

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Frequently asked questions about GSK1322888

What is GSK1322888 used for?

GSK1322888 is an investigational small molecule being developed for the treatment of gastroparesis, a gastrointestinal condition. It is currently in Phase 1 clinical development. The drug is being studied to evaluate its safety, tolerability, and pharmacokinetics in healthy volunteers.

Who makes GSK1322888?

GSK1322888 is being developed by GSK plc, a global biopharmaceutical company. GSK plc is publicly traded under the ticker symbol GSK. The company is conducting clinical trials to evaluate the safety and tolerability of this investigational drug.

What phase is GSK1322888 in?

GSK1322888 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 1 trial is designed to assess the safety, tolerability, and pharmacokinetics of single oral doses of the drug in healthy volunteers.

What clinical trials is GSK1322888 in?

GSK1322888 has one completed Phase 1 clinical trial with the identifier NCT01294566. The trial was a first-time-in-human study evaluating the safety, tolerability, and pharmacokinetics of single oral doses of GSK1322888 in healthy Caucasian and Japanese volunteers. The study enrolled 17 participants and was conducted in Australia.

Is GSK1322888 the same as any other drug?

GSK1322888 is the primary name for this investigational drug. No alternative names have been associated with this compound in the available clinical trial information. It is being studied under this identifier in the clinical trial registry.