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Bioequivalence and Food Effect Study in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT00495274
Recruitment Status : Completed
First Posted : July 3, 2007
Last Update Posted : August 7, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

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.

Condition or disease Intervention/treatment Phase
Sleep Initiation and Maintenance Disorders Drug: Formulation A Drug: Formulation B Drug: Formulation C Drug: Formulation D Drug: Formulation E Drug: Formulation F Drug: Formulation G Phase 1

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : July 2, 2007
Actual Primary Completion Date : September 26, 2007
Actual Study Completion Date : September 26, 2007

Arm Intervention/treatment
Experimental: Healthy male subjects
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
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.
Other Name: SB-649868

Drug: Formulation B
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.

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

Drug: Formulation D
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.

Drug: Formulation E
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.

Drug: Formulation F
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.

Drug: Formulation G
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 Measures :
  1. -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 ]
  2. -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 Measures :
  1. -AE, Lab values and cardiovascular monitoring throughout study participation [ Time Frame: throughout study participation ]
  2. -Romberg heel-to-toe test at discharge [ Time Frame: at discharge ]
  3. -Cognitive functions predose, 0.5, 1, 2, 4, 6 hours post-dose [ Time Frame: predose, 0.5, 1, 2, 4, 6 hours post-dose ]
  4. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00495274


Locations
Italy
GSK Investigational Site
Verona, Veneto, Italy, 37134
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline

Additional Information:
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00495274     History of Changes
Other Study ID Numbers: OXS105205
First Posted: July 3, 2007    Key Record Dates
Last Update Posted: August 7, 2017
Last Verified: August 2017

Keywords provided by GlaxoSmithKline:
Bioequivalent
pharmacodynamic
Reference formulation
5 new formulation
Food effect
Pharmacokinetics

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders