Clinical trial NCT00495274: Bioequivalence and Food Effect Study in Healthy Volunteers
Official title: A Single-centre, Open-label, Randomized, Single-dose, 6-way Crossover Study to Investigate the Pharmacokinetics, Safety and Tolerability of 6 Different Formulations of SB-649868 30 mg (Part A) and the Effect of Food on the Selected Formulation of SB-649868 Pharmacokinetic (Part B) in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Sleep Initiation and Maintenance Disorders
Keywords: Bioequivalent
pharmacodynamic
Reference formulation
5 new formulation
Food effect
Pharmacokinetics
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2007-07-03
Enrollment: 16
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to select the formulation with the optimal pharmacokinetic profile for an hypnotic drug to further develop in the market.

Detailed description: A single-centre, open-label, randomized, single-dose, 6-way crossover study to investigate the pharmacokinetics, safety and tolerability of 6 different formulations of SB-649868 30 mg (Part A) and the effect of food on the selected formulation of SB-649868 pharmacokinetic (Part B) in healthy male volunteers

Eligibility criteria: Inclusion criteria:

* Healthy adult male subjects aged between 18 and 65 years of age inclusive.
* Body weight and BMI within the protocol ranges.
* Healthy as determined by a responsible physician, based on a medical evaluation including history, physical examination, laboratory tests, cardiac monitoring.
* Circulating levels of LH, FSH and testosterone within the normal reference range.
* Signed and dated written informed consent.
* The subject is able to understand and comply with protocol requirements, instructions and protocol-stated restrictions.

Exclusion criteria:

* Positive pre-study urine drug screen and alcohol breath test.
* Positive pre-study Hepatitis B surface antigen, Hepatitis C antibody, or HIV ½ result.
* Abuse of alcohol as per protocol criteria.
* Consumption of prohibited food and drink as per protocol.
* Subject who is not prepared to eat the standard meals provided by the site.
* Use of prescription or non-prescription drugs 1 or 2 weeks before the first dose of study medication.
* Where participation in study would result in donation of blood in excess of 500mL within a 56 day period.
* History or presence of allergy to the study drug or drugs of this class, or a history of other allergy.
* Smoking history in the last three months as per protocol.
* An unwillingness of male subjects to follow contraception methods as per protocol.
* History or presence of significant psychiatric, respiratory or gastrointestinal illnesses, hepatic or renal diseases or other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs.
* The subject is unable or unwilling to abstain from strenuous physical activity in the 48 hours before screening and in the 48 hours before and the 48 hours after the treatment period.
* Current or previous (within 6 months) participation in a clinical trial.

Primary outcomes:
measure: -Part A: SB-649868 levels of 6 formulation predose, 0.5, 1, 1.5, 2,3,4,5,6,8,12 and 24hours post-dose
timeFrame: predose, 0.5, 1, 1.5, 2,3,4,5,6,8,12 and 24hours post-dose
measure: -Part B: SB-649868 levels of selected formulation after food at the same timepoints as in Part A
timeFrame: predose, 0.5, 1, 1.5, 2,3,4,5,6,8,12 and 24hours post-dose
Secondary outcomes:
measure: -AE, Lab values and cardiovascular monitoring throughout study participation
timeFrame: throughout study participation
measure: -Romberg heel-to-toe test at discharge
timeFrame: at discharge
measure: -Cognitive functions predose, 0.5, 1, 2, 4, 6 hours post-dose
timeFrame: predose, 0.5, 1, 2, 4, 6 hours post-dose
measure: Pharmacodynamic endpoint: Bond Lader Visual Analogue Scale (VAS) score
timeFrame: pre-dose, 0.5, 1, 2, 4, 6 hours post-dose on Day 1
Other outcomes:
Locations:
city: Verona
country: Italy
facility: GSK Investigational Site
state: Veneto
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: