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

Substance Dependence Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00728052
• Other study ID #: DAN111282
• 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
• 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

Related Conditions & MeSH terms

• Substance Dependence
• Substance-Related Disorders

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

External Links

•   Results for study DAN111282 can be found on the GSK Clinical Study Register.