A Human Volunteer Study Investigating Single Oral Doses of GSK598809 in Otherwise Healthy Smokers

NCT ID: NCT00728052

Last Updated: 2017-08-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-06-09
• Study Completion Date: 2008-08-19

Brief Summary

Study to investigate the safety, tolerability and pharmacokinetics of GSK598809 in otherwise healthy volunteers. This study is required because this drug is being developed for the treatment of nicotine dependence. It is important to evaluate how this drug interacts in healthy smokers. The study is planned to consist of a single part, with 4 dosing periods. Subjects will receive 3 escalating doses of GSK598809 and 1 dose of placebo. There will be at least 1 week of wash out between doses. In each dosing period 14 subjects will receive escalating doses and 4 subjects will receive placebo. The actual doses used will be determined based on the safety/ tolerability and pharmacokinetics during the previous dose. It is expected that the duration of this study will be approximately 10 weeks.

Conditions

Substance Dependence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Subjects receiving treatment sequence ABCD

Subjects will receive treatment sequence ABCD; A= placebo, B= GSK598809 dose 1 (75 milligrams), C = GSK598809 dose 2, and D = GSK598809 dose 3.

Group Type: EXPERIMENTAL

GSK598809

Intervention Type: DRUG

GSK598809 capsules will be available with dose strengths of 5 milligrams and 25 milligrams, administered orally with water.

Placebo

Intervention Type: DRUG

Placebo capsules will be administered orally with water.

Subjects receiving treatment sequence BACD

Subjects will receive treatment sequence BACD; B= GSK598809 dose 1 (75 milligrams), A= placebo, C = GSK598809 dose 2 and D = GSK598809 dose 3

Group Type: EXPERIMENTAL

GSK598809

Intervention Type: DRUG

GSK598809 capsules will be available with dose strengths of 5 milligrams and 25 milligrams, administered orally with water.

Placebo

Intervention Type: DRUG

Placebo capsules will be administered orally with water.

Subjects receiving treatment sequence BCAD

Subjects will receive treatment sequence BCAD; B= GSK598809 dose 1 (75 milligrams), C = GSK598809 dose 2, A= placebo and D = GSK598809 dose 3.

Group Type: EXPERIMENTAL

GSK598809

Intervention Type: DRUG

GSK598809 capsules will be available with dose strengths of 5 milligrams and 25 milligrams, administered orally with water.

Placebo

Intervention Type: DRUG

Placebo capsules will be administered orally with water.

Subjects receiving treatment sequence BCDA

Subjects will receive treatment sequence BCDA; B= GSK598809 dose 1 (75 milligrams), C = GSK598809 dose 2, D = GSK598809 dose 3 and A= placebo.

Group Type: EXPERIMENTAL

GSK598809

Intervention Type: DRUG

GSK598809 capsules will be available with dose strengths of 5 milligrams and 25 milligrams, administered orally with water.

Placebo

Intervention Type: DRUG

Placebo capsules will be administered orally with water.

Interventions

GSK598809

GSK598809 capsules will be available with dose strengths of 5 milligrams and 25 milligrams, administered orally with water.

Intervention Type: DRUG

Placebo

Placebo capsules will be administered orally with water.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• A healthy man or woman
• 18 - 50 years old
• Neither too fat, nor too thin
• Female subjects must use an acceptable method of contraception from the first dose of study medication until 90 days following the final follow-up visit.
• Female subjects must not be breast feeding and should not have been breast feeding for a month.
• Male subjects must agree to use an acceptable method of contraception from the first dose of study medication until 90 days following the final follow-up.
• Subjects need to smoke 20 - 40 cigarettes a day inclusive for at least the past year and to not have tried to quit in the 3 months before the start of the study.

Exclusion:

• Any current medical or psychiatric illness
• Any history of chronic medical or psychiatric illnesses
• Previous or current alcohol or drug abuse/dependence including nicotine
• Personal or family history of prolonged QTc syndrome

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Berlin, , Germany

Countries

Germany

Other Identifiers

DAN111282

Identifier Type: -

Identifier Source: org_study_id