Recent Updates
Recently added Catalysts

GSK2110183 Gelatin

Phase 1

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

GSK2110183 Gelatin target and mechanism

ModalitySmall molecule

Also known as GSK2110183 Gelatin Capsule

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment18

FDA Designations

No designations recorded

GSK2110183 Gelatin clinical trials

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
Unlock Study Endpoints

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
Unlock Study Design Details

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
Unlock Eligibility Criteria

Competitive Landscape -Cancer 7 trials

Unlock Competitive Intelligence

Frequently asked questions about GSK2110183 Gelatin

What is GSK2110183 Gelatin?

GSK2110183 Gelatin is an investigational small molecule formulation of GSK2110183 developed by GSK plc for use in cancer. It is a gelatin capsule form studied in a Phase 1 bioavailability and food effect trial. It is also known as GSK2110183 Gelatin Capsule.

What is GSK2110183 Gelatin used for?

GSK2110183 Gelatin is being studied in cancer, within the oncology therapeutic area. Its only recorded clinical trial enrolled healthy adult volunteers to assess the bioavailability and food effect of the gelatin formulation compared with an immediate release tablet formulation of afuresertib.

Who makes GSK2110183 Gelatin?

GSK2110183 Gelatin is developed by GSK plc, which trades under the ticker GSK. The company sponsored the Phase 1 bioavailability and food effect study of the gelatin formulation and the immediate release tablet formulation of afuresertib.

What phase is GSK2110183 Gelatin in?

GSK2110183 Gelatin is in Phase 1 development. It is investigational and has not been approved for any indication. The single recorded trial, NCT02040480, is a completed Phase 1 study with 18 enrolled participants conducted in Australia.

What clinical trials is GSK2110183 Gelatin in?

GSK2110183 Gelatin has been studied in one clinical trial, NCT02040480, titled Bioavailability and Food Effect Study of Gelatin Formulation and Immediate Release Tablet Formulation of Afuresertib. It was a completed Phase 1 controlled study with 18 participants, conducted in Australia in healthy volunteers aged 18 years and older.

Is GSK2110183 Gelatin the same as GSK2110183 Gelatin Capsule?

Yes, GSK2110183 Gelatin and GSK2110183 Gelatin Capsule refer to the same investigational product from GSK plc. The capsule name describes the gelatin capsule dosage form studied in the Phase 1 bioavailability and food effect trial NCT02040480.