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GSK2110183 Gelatin

Phase 1

Cancer | Small molecule | Oncology |GSK plc|Last Updated: Nov 13, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment18

FDA Designations

No designations recorded

Clinical trial landscape

GSK2110183 Gelatin · 1 trial · 1 indication

Phase 1 1
NCT02040480Bioavailability and Food Effect Study of Gelatin Formulation and Immediate Release Tablet Formulation of AfuresertibCancer
COMPLETED18 Analytics
PHASE1COMPLETED
Bioavailability and Food Effect Study of Gelatin Formulation and Immediate Release Tablet Formulation of Afuresertib
CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Composite of pharmacokinetic (PK) parameters to determine relative bioavailability of afuresertib after administering it as a single dose in an original gelatin capsule in the fasted state and in a newly formulated IR tablet in the fed and fasted state.
PK Samples will be collected Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 120, and 168 hours post-dose

PK parameters include: area under the plasma concentration-time curve from time zero to infinity (AUC \[0-infinity\]), area under the plasma concentration time curve from time zero to last time of quantifiable concentration (AUC \[0-t\]), maximum observed plasma concentration (Cmax), and time to Cmax (tmax).

Secondary Endpoints

Number of subjects with adverse events (AEs).
Up to 9 weeks
Clinical laboratory parameter assessment as a measure of safety and tolerability
Up to 9 weeks
Concomitant medications review as a measure of safety and tolerability
Up to 9 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Sequence 1EXPERIMENTALParticipants will receive treatment in following sequence in each of the three study periods (one treatment per period): ABC
Sequence 2EXPERIMENTALParticipants will receive treatment in following sequence in each of the three study periods (one treatment per period): ACB
Sequence 3EXPERIMENTALParticipants will receive treatment in following sequence in each of the three study periods (one treatment per period): BAC
Sequence 4EXPERIMENTALParticipants will receive treatment in following sequence in each of the three study periods (one treatment per period): BCA
Sequence 5EXPERIMENTALParticipants will receive treatment in following sequence in each of the three study periods (one treatment per period): CAB
Sequence 6EXPERIMENTALParticipants will receive treatment in following sequence in each of the three study periods (one treatment per period): CBA

Interventions

NameTypeDescription
GSK2110183 Gelatin CapsuleDRUGWhite opaque hard gelatin capsule with a unit dose strength of 25 milligrams (mg) for oral administration
GSK2110183 IR TabletDRUGWhite round biconvex film coated IR tablet with a unit dose strength of 25 mg for oral administration
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Eligibility Criteria

Age Range18 Years to 40 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Provided signed written informed consent * Healthy Male or female between 18 and 40 years of age inclusive, at the time the informed consent is obtained. * Body weight \>=50 kilograms (kg) and body mass index (BMI) of \>=18 and \<= 32 kg/meter square (m\^2). * A female subject...

Countries:Australia
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Frequently asked questions about GSK2110183 Gelatin

What is GSK2110183 Gelatin?

GSK2110183 Gelatin is an investigational small molecule being developed by GSK plc for the treatment of cancer. It is currently in Phase 1 clinical development. The drug is being studied in a completed clinical trial that evaluated its bioavailability and food effects.

What is GSK2110183 Gelatin used for?

GSK2110183 Gelatin is being studied for use in cancer. It is an investigational oncology drug in Phase 1 clinical development. The completed clinical trial enrolled patients with cancer to assess the drug's bioavailability and the effect of food on its absorption.

Who makes GSK2110183 Gelatin?

GSK2110183 Gelatin is developed by GSK plc, a pharmaceutical company listed on the stock exchange under the ticker symbol GSK. The drug is an investigational small molecule being studied for the treatment of cancer.

What phase is GSK2110183 Gelatin in?

GSK2110183 Gelatin is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 clinical trial has been completed, and the drug remains under investigation for cancer.

What clinical trials is GSK2110183 Gelatin in?

GSK2110183 Gelatin has one completed clinical trial, NCT02040480, titled "Bioavailability and Food Effect Study of Gelatin Formulation and Immediate Release Tablet Formulation of Afuresertib." This Phase 1 study enrolled 18 participants in Australia and evaluated the drug in cancer patients.