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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00728052

Enrollment

Registered

2008-08-05

Start date

2008-06-09

Completion date

2008-08-19

Last updated

2017-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Substance Dependence

Keywords

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

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.

Interventions

DRUGGSK598809

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

DRUGPlacebo

Placebo capsules will be administered orally with water.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

Yes

Inclusion 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

Design outcomes

Primary

Measure	Time frame
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.	48 hours post dose

Secondary

Measure	Time frame
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.	24 hours

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026