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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00728052
Other study ID # DAN111282
Secondary ID
Status Completed
Phase Phase 1
First received August 1, 2008
Last updated August 1, 2017
Start date June 9, 2008
Est. completion date August 19, 2008

Study information

Verified date August 2017
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 18
Est. completion date August 19, 2008
Est. primary completion date August 19, 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 50 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Germany GSK Investigational Site Berlin

Sponsors (1)

Lead Sponsor Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
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