First Time in Human Study With GSK1018921

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 1

Conditions: Schizophrenia

Treatments: Drug: GSK1018921; Drug: Nicotine Lozenges; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00527020

GT1109727

Details and patient eligibility

About

GSK1018921 is a new drug under development for the treatment of schizophrenia. GSK1018921 differs from other available drugs in its mode of action and it is assumed that it may have an effect in the treatment of so-called positive symptoms such as hallucinations and negative symptoms such as lack of drive. No clinical studies have been conducted with GSK1018921 in humans until now. This is the first study where this compound is administered to humans; the study has 2 parts: Part A is a dose escalation study, Part B is a pharmacodynamic portion in a separate group of healthy smoker volunteers.

Full description

Single-Blind, Randomised, Placebo-Controlled First Time in Human Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Oral Escalating Doses of GSK1018921 in Healthy Volunteers and to assess the effect of a single dose of GSK1018921 on quantitative EEG and Mismatch Negativity in a separate cohort of healthy smoker volunteers

Enrollment: 27 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy volunteers as determined by a responsible physician, based on a medical evaluation including history, physical examination, laboratory tests, cardiac monitoring.
• For Part B, smokers.

Exclusion criteria

• Part A: Smokers, any subject who takes any prescribed or non-prescribed medication/vitamins specified as prohibited in the protocol, substance abuse, clinically significant disease as determined by a responsible physician.
• Part B: Non-Smokers

Trial design

27 participants in 5 patient groups

Part A: Subjects receiving treatment in cohort A

Experimental group

Description:

Eligible subjects will be randomized to receive GSK101892 and placebo. Subjects will receive escalated doses of GSK101892 with a starting dose of 0.5 milligrams. Each subject will receive no more than 4 doses of GSK1018921 in a maximum of 5 dosing sessions. Within each cohort, each session will be separated by a washout period of at least 7 days.

Treatment:

Drug: GSK1018921

Drug: Nicotine Lozenges

Drug: Placebo

Part A: Subjects receiving treatment in cohort B

Experimental group

Description:

Eligible subjects will be randomized to receive GSK101892 and placebo. Subjects will receive escalated doses of GSK101892 with a starting dose of 0.5 milligrams. Each subject will receive no more than 4 doses of GSK1018921 in a maximum of 5 dosing sessions. Within each cohort, each session will be separated by a washout period of at least 7 days.

Treatment:

Drug: GSK1018921

Drug: Nicotine Lozenges

Drug: Placebo

Part A: Subjects receiving treatment in cohort C

Experimental group

Description:

Eligible subjects will be randomized to receive GSK101892 and placebo. Subjects will receive escalated doses of GSK101892 with a starting dose of 0.5 milligrams. Each subject will receive no more than 4 doses of GSK1018921 in a maximum of 5 dosing sessions. Within each cohort, each session will be separated by a washout period of at least 7 days.

Treatment:

Drug: GSK1018921

Drug: Nicotine Lozenges

Drug: Placebo

Part B: Subjects in 5 period crossover period

Experimental group

Description:

Eligible subjects (first 14 subjects) will be randomized to one of the following 14 sequences as a 5 period crossover with sequences; LMNOQ, MNOLQ, NOLMQ, OLMNQ, ONMLQ, NMLOQ, MLONQ, LONMQ, LNMOQ, NMOLQM MOLNQ, OLNMQ, OMNLQ and MNLOQ) (L= 80 milligrams GSK1018921 given in fasted state, M= 200 milligrams GSK1018921 given in fasted state, N= nicotine lozenge, O= placebo and Q= 80 milligrams GSK1018921 in fed state).

Treatment:

Drug: GSK1018921

Drug: Nicotine Lozenges

Drug: Placebo

Part B: Subjects in 4 period crossover period

Experimental group

Description:

Eligible subjects (last 7 subjects) will be randomized to one of the following 7 sequences as a 4 period crossover with sequences; NLOM, LOMN, OLNM, LNMO, NMOL, MOLN, and MNLO.

Treatment:

Drug: GSK1018921

Drug: Nicotine Lozenges

Drug: Placebo