Sleep Initiation and Maintenance DisordersPhase 1NCT00495274
Bioequivalence and Food Effect Study in Healthy Volunteers
A Phase 1 study testing Formulation A, Formulation B and Formulation C in people with Sleep Initiation and Maintenance Disorders, run by GlaxoSmithKline at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Sleep Initiation and Maintenance Disorders
- What is being tested?
- Formulation A, Formulation B and Formulation C
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteItaly
- Study dates
- 2 Jul 2007to 26 Sep 2007
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Being tested
- Formulation A, Formulation B, Formulation C, Formulation D, Formulation E
- Keywords
- Bioequivalent, pharmacodynamic, Reference formulation, 5 new formulation, Food effect, Pharmacokinetics
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Formulation ADrug
Also called SB-649868
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.
Formulation BDrug
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.
Formulation CDrug
Formulation C will represent SB-649868 10 mg lipophilic capsule (3 capsules to reach 30 mg). Formulation C will be administered in Part A.
Formulation DDrug
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.
Formulation EDrug
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.
Formulation FDrug
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.
Formulation GDrug
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Formulation A; Drug: Formulation B; Drug: Formulation C; Drug: Formulation D; Drug: Formulation E; Drug: Formulation F; Drug: Formulation G |
What is being measured
The primary outcome is the main question the study is designed to answer.
-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
Measured: 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
Measured: 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
Measured: throughout study participation
-Romberg heel-to-toe test at discharge
Measured: at discharge
-Cognitive functions predose, 0.5, 1, 2, 4, 6 hours post-dose
Measured: predose, 0.5, 1, 2, 4, 6 hours post-dose
Pharmacodynamic endpoint: Bond Lader Visual Analogue Scale (VAS) score
Measured: pre-dose, 0.5, 1, 2, 4, 6 hours post-dose on Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2007 (estimated)
- Study start2 Jul 2007
- Primary completion26 Sep 2007
- Study completion26 Sep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Initiation and Maintenance DisordersStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00495274
- Sponsor's protocol ID
- OXS105205
- Status last verified
- Aug 2017
- First submitted
- 29 Jun 2007
- Last updated
- 7 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00495274
- Acronym / sponsor ID
- OXS105205
- Keywords
- Bioequivalent, pharmacodynamic, Reference formulation, 5 new formulation, Food effect, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 2 Jul 2007 (actual)
- Primary completion
- 26 Sep 2007 (actual)
- Study completion
- 26 Sep 2007 (actual)
- First posted
- 3 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy male subjects | Experimental | Drug: Formulation A, Drug: Formulation B, Drug: Formulation C, Drug: Formulation D, Drug: Formulation E, Drug: Formulation F, Drug: Formulation GIn 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Formulation AAlso: SB-649868Formulation 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. | Drug | Healthy male subjects |
| Formulation BFormulation 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 | Healthy male subjects |
| Formulation CFormulation C will represent SB-649868 10 mg lipophilic capsule (3 capsules to reach 30 mg). Formulation C will be administered in Part A. | Drug | Healthy male subjects |
| Formulation DFormulation 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 | Healthy male subjects |
| Formulation EFormulation 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 | Healthy male subjects |
| Formulation FFormulation 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 | Healthy male subjects |
| Formulation GFormulation 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 | Drug | Healthy male subjects |
Primary outcome
-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
-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
4 secondary outcomes
-AE, Lab values and cardiovascular monitoring throughout study participation
Time frame: throughout study participation
-Romberg heel-to-toe test at discharge
Time frame: at discharge
-Cognitive functions predose, 0.5, 1, 2, 4, 6 hours post-dose
Time frame: predose, 0.5, 1, 2, 4, 6 hours post-dose
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2017.
- Results for study OXS105205 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
Related trials for Sleep Initiation and Maintenance Disorders
Recruiting
Addressing Nocturia in Older Women Utilizing Behavioral Sleep Intervention and Brief Mindfulness
Nocturia, Insomnia
Not yet recruiting
A Transdiagnostic Sleep Health Intervention for Veterans With PTSD
Stress Disorders, Post-Traumatic, Sleep Initiation and Maintenance Disorders
Recruiting
Effect of Cyclic Sighing Breathing Exercise on CRBD, Pain, and Sleep Quality in Patients Undergoing TUR
Transurethral Resection of Bladder Tumor, Transurethral Resection of the Prostate (TURP)
Recruiting
Treating Insomnia in Mild Cognitive Impairment
Mild Cognitive Impairment (MCI), Insomnia
RecruitingPhase 4
The Effects of Orexin Antagonism on Fear Extinction in PTSD
Insomnia, PTSD
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Formulation A, Formulation B and Formulation C in people with Sleep Initiation and Maintenance Disorders, run by GlaxoSmithKline at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: predose, 0.5, 1, 1.5, 2,3,4,5,6,8,12 and 24hours post-dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2017.