Alzheimer's DiseasePhase 1Rosi XRNCT00733785
PK, Dose Proportionality, Food Effect And Repeat Dose Study Of Rosiglitazone XR In Healthy Volunteers
A Phase 1 study testing Rosiglitazone XR in people with Alzheimer's Disease, run by GlaxoSmithKline at 1 site in Germany.
Trial summary
The present pharmacokinetic study is designed to further characterise the pharmacokinetics of the RSG XR formulation and aims to assess dose proportionality, strength equivalence, the food effect and the pharmacokinetics after repeat dosing. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- Rosiglitazone XR
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- 13 Aug 2008to 28 Nov 2008
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- A subject will be eligible for inclusion in this study only if all of the following criteria apply:
- Healthy male and female (not gender stratified) subjects aged 18-55 years inclusive - healthy subjects are defined as individuals who are free from clinically significant illness or disease as determined by their medical history, physical examination, laboratory studies, ECGs, and other tests. A subject with clinical abnormality or laboratory parameters outside the reference range for this age group may be included only if the Investigator and the GSK Medical Monitor considers that the findings will not introduce additional risk factors and will not interfere with the study procedures.
- Body weight greater than 50 kg (110lbs and Body mass index (BMI) between 19 and 30 kg/m2 Willing and able to give written informed consent, willing to participate for the full duration of the study, and able to understand and follow instructions related to study procedures.
- Female subjects able to bear children must agree to use an adequate method of contraception for the duration of the study and for 14 days after last dose (see for details of highly effective methods to avoid pregnancy). Female subjects who are pre-menopausal or who have been post-menopausal for less than 2 years must undertake pregnancy testing (serum test) less than or equal to 7 days before Visit 1, which must be negative
- Females, who are on hormone replacement therapy (HRT), and whose menopausal status is in doubt, will be required to use a highly effective method to avoid pregnancy, as outlined in the protocol, if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrollment. For most forms of HRT, at least 2-4 weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post-menopausal status, they can resume use of HRT during the study without use of a highly effective method to avoid pregnancy.
Who cannot join
- A subject will not be eligible for inclusion in this study if any of the following criteria apply:
- Any clinically relevant abnormality identified on the screening history and physical or laboratory examination or any other medical condition or circumstance making the volunteer unsuitable for participation in the study. Specific examples include, coronary artery disease, myocardial infarction, congestive heart failure, type 2 diabetes, renal disease and hypertension. If there is doubt on the appropriateness of a subject, that subject's eligibility for the study must be reviewed with the medical monitor prior to enrolment.
- History of surgical procedures that might affect the absorption of rosiglitazone (e.g., partial/total gastrectomy, cholecystectomy) or any hepatic or biliary abnormalities such as Gilbert's syndrome.
- History of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for men (1 drink = 150mls of wine or 360mls of beer or 45mls of hard liquor) within 6 months of screening.
- Subject smoking more than 10 cigarettes per day. Positive urine drug screen (UDS) including alcohol at screening or check-in visits.
- Positive hepatitis B virus, hepatitis C virus or HIV test at screening. Positive serum beta-human chorionic gonadotropin test (females). Women who are pregnant, lactating, or planning to become pregnant. Male subjects who are not willing to abstain from or use a condom during sexual intercourse with pregnant or lactating females. Male subjects not willing to use a condom, plus another form of contraception (e.g., spermicide, IUD, birth control pills taken by female partner, diaphragm with spermicide) if engaging in sexual intercourse with a female who could become pregnant. Male subjects not willing to adhere to these contraceptive criteria from administration of study medication until completion of follow-up procedures.
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- Female subjects not willing to use proposed contraceptive methods. Use of prescription or non-prescription drugs [in particular known inhibitors of cytochrome 2C8 (Gemfibrozil, trimethoprim, glitazone, monteleucast, quercetin) or inducer (rifampin)], vitamins, herbal and dietary supplements (including St. John's Wort) within 14 days or 5 half-lives (whichever is longer) prior to the first dose of study medication. Excluded from this list are acetaminophen and paracetamol at doses of less than or equal to 2 grams/day, thyroid replacement therapy, and hormonal methods of contraception (including oral contraceptives, injectable progesterone, progestin subdermal implants and progesterone-releasing IUDs, but NOT postcoital contraceptive methods) and hormone replacement therapy which will be permitted throughout the study.
- Donation of blood in excess of 500 mL within 56 days prior to first dose of study medication.
- History of sensitivity to heparin, heparin-induced thrombocytopenia or sensitivity to any of the study medications or components thereof.
- History of hypersensitivity to rosiglitazone, or any of the excipients in the formulations.
- Systolic BP greater than 140 mm Hg and/or Diastolic BP greater than 90 mm Hg at screening or check-in.
- QTc (machine read) greater than 450 ms on the screening ECG. History of glucose intolerance (serum glucose greater than 110 mg/dl or 6.1 mmol/L after 8 hours fasting) Subjects have had treatment with a new molecular entity (investigational drug) or any other trial during the previous 30 days or five half-lives, whichever is longer. (the washout is from last dose of study medication in the previous study until the first dose of study medication).
- Current evidence of drug abuse or history of drug abuse within one year of allocation Inability to understand the protocol requirements, instructions and study-related restrictions, the nature, scope, and possible consequences of the study Unlikely to comply with the protocol requirements, instructions and study-related restrictions; e.g., uncooperative attitude, inability to return for follow-up visits, and improbability of completing the study Subject is the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the study.
- Vulnerable subjects (e.g. persons kept in detention).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label, Randomized, Crossover Study to the Dose Proportionality of RSG XR in Healthy Volunteers in Fasting Conditions
The present pharmacokinetic study is designed to further characterise the pharmacokinetics of the RSG XR formulation and aims to assess dose proportionality, strength equivalence, the food effect and the pharmacokinetics after repeat dosing.
Read the detailed description
The present pharmacokinetic study is designed to further characterise the pharmacokinetics of the RSG XR formulation manufactured in Crawley and aims to assess dose proportionality, strength equivalence, the food effect and the pharmacokinetics after repeat dosing. The study aims to enroll sufficient number of subjects to ensure 48 subjects complete Study Part 1 (6 period crossover design) and a further 12 subjects complete Study Part 2 (repeat dosing).
- Conditions
- Alzheimer's Disease
- Being tested
- Rosiglitazone XR
- Keywords
- Rosiglitazone XR, Pharmacokinetics, Strength Equivalence., Alzheimers Disease, Repeat dose, Dose proportionality
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rosiglitazone XRDrug
Rosiglitazone extended release formulation
| Study group | Role | What they receive |
|---|---|---|
| 2mg tablet | Experimental | 2 mg tablet fasted Receives: Drug: Rosiglitazone XR |
| 4 mg tablet | Experimental | 4 mg tablet fasted Receives: Drug: Rosiglitazone XR |
| 8mg tablet | Experimental | 8 mg tablet fasted Receives: Drug: Rosiglitazone XR |
| 2 x 4 mg tablets | Experimental | 2 x 4mg tablets fasting Receives: Drug: Rosiglitazone XR |
| 2 x 2mg tablets | Experimental | 2 x 2mg tablets fasting Receives: Drug: Rosiglitazone XR |
| 8 mg tablet fed | Experimental | 8 mg tablet fed Receives: Drug: Rosiglitazone XR |
| Repeat dose | Experimental | 8 mg once a day for 6 days Receives: Drug: Rosiglitazone XR |
What is being measured
The primary outcome is the main question the study is designed to answer.
•For the single dose period: AUC(0-inf) and Cmax of RSG XR.•For repeat dose period on Day 1 and 6:, AUC(0-24) and Cmax of RSG XR.
Measured: Single dose and Day 6 for repeat dose
Secondary outcomes (4)
For single dose period: AUC(0-t), Tmax, lz, and t1/2 of RSG XR as data permit
Measured: Single dose and Day 6 for repeat dose
For repeat dose period: Tmax, concentration at the end of the dosing interval (Ct), minimum observed concentration (Cmin),
Measured: 6 days
Average concentration during a dosing interval (Cav), t1/2, , accumulation ratio(Rs) Rs= (AUC(0-t) last day)/(AUC(0-t) first day) and degree of fluctuation DF= (Cmax-Cmin)/Cave.
Measured: 6 days
• Safety reporting (adverse events, laboratory testing, ECG, vital signs)
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2008 (estimated)
- Study start13 Aug 2008
- Primary completion28 Nov 2008
- Study completion28 Nov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies 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
- 60 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
- NCT00733785
- Sponsor's protocol ID
- AVA109939
- Acronym
- Rosi XR
- Status last verified
- Jul 2017
- First submitted
- 12 Aug 2008
- Last updated
- 21 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Randomized, Crossover Study to the Dose Proportionality of RSG XR in Healthy Volunteers in Fasting Conditions
- ClinicalTrials.gov ID
- NCT00733785
- Acronym / sponsor ID
- Rosi XR / AVA109939
- Conditions
- Alzheimer's Disease
- Keywords
- Rosiglitazone XR, Pharmacokinetics, Strength Equivalence., Alzheimers Disease, Repeat dose, Dose proportionality
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 13 Aug 2008 (actual)
- Primary completion
- 28 Nov 2008 (actual)
- Study completion
- 28 Nov 2008 (actual)
- First posted
- 13 Aug 2008 (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 present pharmacokinetic study is designed to further characterise the pharmacokinetics of the RSG XR formulation and aims to assess dose proportionality, strength equivalence, the food effect and the pharmacokinetics after repeat dosing.
Detailed description
The present pharmacokinetic study is designed to further characterise the pharmacokinetics of the RSG XR formulation manufactured in Crawley and aims to assess dose proportionality, strength equivalence, the food effect and the pharmacokinetics after repeat dosing. The study aims to enroll sufficient number of subjects to ensure 48 subjects complete Study Part 1 (6 period crossover design) and a further 12 subjects complete Study Part 2 (repeat dosing).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| 2mg tablet | Experimental | Drug: Rosiglitazone XR2 mg tablet fasted |
| 4 mg tablet | Experimental | Drug: Rosiglitazone XR4 mg tablet fasted |
| 8mg tablet | Experimental | Drug: Rosiglitazone XR8 mg tablet fasted |
| 2 x 4 mg tablets | Experimental | Drug: Rosiglitazone XR2 x 4mg tablets fasting |
| 2 x 2mg tablets | Experimental | Drug: Rosiglitazone XR2 x 2mg tablets fasting |
| 8 mg tablet fed | Experimental | Drug: Rosiglitazone XR8 mg tablet fed |
| Repeat dose | Experimental | Drug: Rosiglitazone XR8 mg once a day for 6 days |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- A subject will be eligible for inclusion in this study only if all of the following criteria apply:
- Healthy male and female (not gender stratified) subjects aged 18-55 years inclusive - healthy subjects are defined as individuals who are free from clinically significant illness or disease as determined by their medical history, physical examination, laboratory studies, ECGs, and other tests. A subject with clinical abnormality or laboratory parameters outside the reference range for this age group may be included only if the Investigator and the GSK Medical Monitor considers that the findings will not introduce additional risk factors and will not interfere with the study procedures.
- Body weight greater than 50 kg (110lbs and Body mass index (BMI) between 19 and 30 kg/m2 Willing and able to give written informed consent, willing to participate for the full duration of the study, and able to understand and follow instructions related to study procedures.
- Female subjects able to bear children must agree to use an adequate method of contraception for the duration of the study and for 14 days after last dose (see for details of highly effective methods to avoid pregnancy). Female subjects who are pre-menopausal or who have been post-menopausal for less than 2 years must undertake pregnancy testing (serum test) less than or equal to 7 days before Visit 1, which must be negative
- Females, who are on hormone replacement therapy (HRT), and whose menopausal status is in doubt, will be required to use a highly effective method to avoid pregnancy, as outlined in the protocol, if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrollment. For most forms of HRT, at least 2-4 weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post-menopausal status, they can resume use of HRT during the study without use of a highly effective method to avoid pregnancy.
Key exclusion criteria (14 listed)
- A subject will not be eligible for inclusion in this study if any of the following criteria apply:
- Any clinically relevant abnormality identified on the screening history and physical or laboratory examination or any other medical condition or circumstance making the volunteer unsuitable for participation in the study. Specific examples include, coronary artery disease, myocardial infarction, congestive heart failure, type 2 diabetes, renal disease and hypertension. If there is doubt on the appropriateness of a subject, that subject's eligibility for the study must be reviewed with the medical monitor prior to enrolment.
- History of surgical procedures that might affect the absorption of rosiglitazone (e.g., partial/total gastrectomy, cholecystectomy) or any hepatic or biliary abnormalities such as Gilbert's syndrome.
- History of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for men (1 drink = 150mls of wine or 360mls of beer or 45mls of hard liquor) within 6 months of screening.
- Subject smoking more than 10 cigarettes per day. Positive urine drug screen (UDS) including alcohol at screening or check-in visits.
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 |
|---|---|---|
| Rosiglitazone XRRosiglitazone extended release formulation | Drug | 2 x 2mg tablets, 2 x 4 mg tablets, 2mg tablet, 4 mg tablet, 8 mg tablet fed, 8mg tablet, Repeat dose |
Primary outcome
•For the single dose period: AUC(0-inf) and Cmax of RSG XR.•For repeat dose period on Day 1 and 6:, AUC(0-24) and Cmax of RSG XR.
Time frame: Single dose and Day 6 for repeat dose
4 secondary outcomes
For single dose period: AUC(0-t), Tmax, lz, and t1/2 of RSG XR as data permit
Time frame: Single dose and Day 6 for repeat dose
For repeat dose period: Tmax, concentration at the end of the dosing interval (Ct), minimum observed concentration (Cmin),
Time frame: 6 days
Average concentration during a dosing interval (Cav), t1/2, , accumulation ratio(Rs) Rs= (AUC(0-t) last day)/(AUC(0-t) first day) and degree of fluctuation DF= (Cmax-Cmin)/Cave.
Time frame: 6 days
• Safety reporting (adverse events, laboratory testing, ECG, vital signs)
Time frame: 8 weeks
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 21 Jul 2017.
- Results for study AVA109939 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
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Aging
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 Rosiglitazone XR in people with Alzheimer's Disease, run by GlaxoSmithKline at 1 site in Germany.
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 5 inclusion and 14 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 21 Jul 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 Germany. 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?
•For the single dose period: AUC(0-inf) and Cmax of RSG XR.•For repeat dose period on Day 1 and 6:, AUC(0-24) and Cmax of RSG XR. (time frame: Single dose and Day 6 for repeat dose). 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 21 Jul 2017.