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

Primary Purpose

Substance Dependence

Status

Completed

Phase

Phase 1

Locations

Germany

Study Type

Interventional

Intervention

GSK598809

Placebo

About this trial

This is an interventional treatment trial for Substance Dependence focused on measuring Tolerability, dose escalation, GSK598809, Pharmacodynamics, Safety, single, placebo, Smokers, Pharmacokinetics

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion:

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

Sites / Locations

GSK Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

Subjects receiving treatment sequence ABCD

Subjects receiving treatment sequence BACD

Subjects receiving treatment sequence BCAD

Subjects receiving treatment sequence BCDA

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

Safety and tolerability: Clinical labs, cardiovascular variables, vital signs, adverse events over 48 hours post dosing and at follow up. Psychological assessment and movement scales will be monitored. Blood Sampling over 48 hours.

Secondary Outcome Measures

Cigarette craving assessed over 24 hours around dosing. Cigarette Consumption to be monitored during the whole study.Withdrawal from nicotine assessed during first four hours of dosing. Cognition/ impulsivity assessed over 24 hours after dosing.

Full Information

NCT ID

NCT00728052

First Posted

August 1, 2008

Last Updated

August 1, 2017

Sponsor

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT00728052

Brief Title

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

Official Title

A Placebo-controlled, Single-blind, Randomised, Human Volunteer Study Investigating the Tolerability and Pharmacokinetics of Escalating Single Oral Doses (75mg and Above) of GSK598809 in Otherwise Healthy Smokers

Study Type

Interventional

2. Study Status

Record Verification Date

August 2017

Overall Recruitment Status

Completed

Study Start Date

June 9, 2008 (Actual)

Primary Completion Date

August 19, 2008 (Actual)

Study Completion Date

August 19, 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

GlaxoSmithKline

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Substance Dependence

Keywords

Tolerability, dose escalation, GSK598809, Pharmacodynamics, Safety, single, placebo, Smokers, Pharmacokinetics

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

18 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Subjects receiving treatment sequence ABCD

Arm Type

Experimental

Arm Description

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

Arm Title

Subjects receiving treatment sequence BACD

Arm Type

Experimental

Arm Description

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

Arm Title

Subjects receiving treatment sequence BCAD

Arm Type

Experimental

Arm Description

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

Arm Title

Subjects receiving treatment sequence BCDA

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

GSK598809

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo capsules will be administered orally with water.

Primary Outcome Measure Information:

Title

Time Frame

48 hours post dose

Secondary Outcome Measure Information:

Title

Time Frame

24 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

GSK Clinical Trials

Organizational Affiliation

GlaxoSmithKline

Official's Role

Study Director

Facility Information:

Facility Name

GSK Investigational Site

City

Berlin

ZIP/Postal Code

13251

Country

Germany

12. IPD Sharing Statement

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

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