Back to resultsBioequivalence and Food Effect Study in Healthy Volunteers
Primary Purpose
Sleep Initiation and Maintenance Disorders
Status
Completed
Phase
Phase 1
Locations
Italy
Study Type
Interventional
Intervention
Formulation A
Formulation B
Formulation C
Formulation D
Formulation E
Formulation F
Formulation G
Sponsored by
About this trial
This is an interventional treatment trial for Sleep Initiation and Maintenance Disorders focused on measuring Bioequivalent, pharmacodynamic, Reference formulation, 5 new formulation, Food effect, Pharmacokinetics
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.
Sites / Locations
- GSK Investigational Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Healthy male subjects
Arm Description
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.
Outcomes
Primary Outcome Measures
-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
-Part B: SB-649868 levels of selected formulation after food at the same timepoints as in Part A
Secondary Outcome Measures
-AE, Lab values and cardiovascular monitoring throughout study participation
-Romberg heel-to-toe test at discharge
-Cognitive functions predose, 0.5, 1, 2, 4, 6 hours post-dose
Pharmacodynamic endpoint: Bond Lader Visual Analogue Scale (VAS) score
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00495274
Brief Title
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
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
July 2, 2007 (Actual)
Primary Completion Date
September 26, 2007 (Actual)
Study Completion Date
September 26, 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Initiation and Maintenance Disorders
Keywords
Bioequivalent, pharmacodynamic, Reference formulation, 5 new formulation, Food effect, Pharmacokinetics
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Healthy male subjects
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Formulation A
Other Intervention Name(s)
SB-649868
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Formulation B
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Formulation C
Intervention Description
Formulation C will represent SB-649868 10 mg lipophilic capsule (3 capsules to reach 30 mg). Formulation C will be administered in Part A.
Intervention Type
Drug
Intervention Name(s)
Formulation D
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Formulation E
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Formulation F
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Formulation G
Intervention Description
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
Primary Outcome Measure Information:
Title
-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
Time Frame
predose, 0.5, 1, 1.5, 2,3,4,5,6,8,12 and 24hours post-dose
Title
-Part B: SB-649868 levels of selected formulation after food at the same timepoints as in Part A
Time Frame
predose, 0.5, 1, 1.5, 2,3,4,5,6,8,12 and 24hours post-dose
Secondary Outcome Measure Information:
Title
-AE, Lab values and cardiovascular monitoring throughout study participation
Time Frame
throughout study participation
Title
-Romberg heel-to-toe test at discharge
Time Frame
at discharge
Title
-Cognitive functions predose, 0.5, 1, 2, 4, 6 hours post-dose
Time Frame
predose, 0.5, 1, 2, 4, 6 hours post-dose
Title
Pharmacodynamic endpoint: Bond Lader Visual Analogue Scale (VAS) score
Time Frame
pre-dose, 0.5, 1, 2, 4, 6 hours post-dose on Day 1
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Verona
State/Province
Veneto
ZIP/Postal Code
37134
Country
Italy
12. IPD Sharing Statement
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Bioequivalence and Food Effect Study in Healthy Volunteers
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