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

NCT00728052 | Completed Phase 1

• 1 other identifier: DAN111282
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (4)

Subjects receiving treatment sequence ABCD

EXPERIMENTAL

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

Drug: GSK598809; Drug: Placebo

Subjects receiving treatment sequence BACD

EXPERIMENTAL

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

Drug: GSK598809; Drug: Placebo

Subjects receiving treatment sequence BCAD

EXPERIMENTAL

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

Drug: GSK598809; Drug: Placebo

Subjects receiving treatment sequence BCDA

EXPERIMENTAL

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

Drug: GSK598809; Drug: Placebo

Interventions

GSK598809 DRUG

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

Subjects receiving treatment sequence ABCD; Subjects receiving treatment sequence BACD; Subjects receiving treatment sequence BCAD; Subjects receiving treatment sequence BCDA

Placebo DRUG

Placebo capsules will be administered orally with water.

Subjects receiving treatment sequence ABCD; Subjects receiving treatment sequence BACD; Subjects receiving treatment sequence BCAD; Subjects receiving treatment sequence BCDA

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• A healthy man or woman
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Berlin, 13251, Germany

Location

Related Links

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

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

GSK598809

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2008
• First Posted: August 5, 2008
• Study Start: June 9, 2008
• Primary Completion: August 19, 2008
• Study Completion: August 19, 2008
• Last Updated: August 3, 2017

Record last verified: 2017-08

Locations

DE (1)