Bioequivalence and Food Effect Study in Healthy Volunteers

NCT00495274 | Completed Phase 1

• 1 other identifier: OXS105205
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Initiation and Maintenance Disorders

Keywords

Bioequivalent; pharmacodynamic; Reference formulation; 5 new formulation; Food effect; Pharmacokinetics

Outcome Measures

Primary Outcomes (2)

• -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

  predose, 0.5, 1, 1.5, 2,3,4,5,6,8,12 and 24hours post-dose

• -Part B: SB-649868 levels of selected formulation after food at the same timepoints as in Part A

  predose, 0.5, 1, 1.5, 2,3,4,5,6,8,12 and 24hours post-dose

Secondary Outcomes (4)

• -AE, Lab values and cardiovascular monitoring throughout study participation

  throughout study participation

• -Romberg heel-to-toe test at discharge

  at discharge

• -Cognitive functions predose, 0.5, 1, 2, 4, 6 hours post-dose

  predose, 0.5, 1, 2, 4, 6 hours post-dose

• Pharmacodynamic endpoint: Bond Lader Visual Analogue Scale (VAS) score

  pre-dose, 0.5, 1, 2, 4, 6 hours post-dose on Day 1

Study Arms (1)

Healthy male subjects

EXPERIMENTAL

In Part A each subject will participate in six sessions and will be administered, in randomized order, single doses of five new formulations (formulation B, C, D, E and F) of SB-649868 30 milligrams (mg), in fasted state and a single dose of the original formulation (formulation A), after a standard Food and Drug Administration (FDA) High-Fat breakfast. All dosing sessions will be separated by a washout session of at least 5 ± 2 days after each dose. In Part B a single dose of the selected SB-649868 30 mg formulation will be administered after a standard FDA High-Fat breakfast.

Drug: Formulation A; Drug: Formulation B; Drug: Formulation C; Drug: Formulation D; Drug: Formulation E; Drug: Formulation F; Drug: Formulation G

Interventions

Formulation A DRUG

Formulation A represents the original formulation. SB-649868 10 mg film coated tablet (3 tablets to reach 30 mg), containing micronized drug substance. Formulation A will be administered in Part A.

Also known as: SB-649868

Healthy male subjects

Formulation B DRUG

Formulation B will represent SB-649868 10 mg film coated tablet containing micronized drug substance (3 tablets to reach 30 mg), but contains additional surfactant. Formulation B will be administered in Part A.

Healthy male subjects

Formulation C DRUG

Formulation C will represent SB-649868 10 mg lipophilic capsule (3 capsules to reach 30 mg). Formulation C will be administered in Part A.

Healthy male subjects

Formulation D DRUG

Formulation D will represent SB-649868 10 mg film coated tablet (3 tablets to reach 30 mg), containing nanomilled and spray dried powder. Formulation D will be administered in Part A.

Healthy male subjects

Formulation E DRUG

Formulation E will represent SB-649868 10 mg capsule (3 capsules to reach 30 mg), containing nanomilled and spray dried powder. Formulation E will be administered in Part A.

Healthy male subjects

Formulation F DRUG

Formulation F will represent SB-649868 15 mg liquid filled capsule (2 capsules to reach 30 mg). Formulation F will be administered in Part A.

Healthy male subjects

Formulation G DRUG

Formulation G will be the selected formulation of SB-649868 30 mg to be assessed in Part B. The formulation will be administered after a standard FDA High-Fat breakfast

Healthy male subjects

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Verona, Veneto, 37134, Italy

Location

Related Links

• Results for study OXS105205 can be found on the GSK Clinical Study Register.

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

N-((1-((5-(4-fluorophenyl)-2-methyl-4-thiazolyl)carbonyl)-2-piperidinyl)methyl)-4-benzofurancarboxamide; D-Worm; Granuflex E

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2007
• First Posted: July 3, 2007
• Study Start: July 2, 2007
• Primary Completion: September 26, 2007
• Study Completion: September 26, 2007
• Last Updated: August 7, 2017

Record last verified: 2017-08

Locations

IT (1)