HealthyPhase 1NCT01168336
Evaluation of Co-Administration of Betahistine as Adjunctive to Olanzapine in Healthy Subjects
A Phase 1 study testing Betahistine standard formulation and Betahistine Extended Release formulation in people with Healthy, run by OBEcure Ltd. at 2 sites in Romania.
Trial summary
The study aims to evaluate the safety and pharmacokinetics of extended release and standard formulations of betahistine when administered as monotherapy and as compared to their safety and pharmacokinetics when co-administered with olanzapine and to determine potential dose limiting toxicities and/or drug-drug… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Betahistine standard formulation and Betahistine Extended Release formulation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 2 sitesRomania
- Study dates
- Jul 2010to Dec 2010
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subjects 18 to 45 years of age and Body Mass Index (BMI)in the range of 18.5 to 27.0
- Male and females
- If female - must be non-lactating and non-pregnant, as measured by negative urine pregnancy test, have no plans to become pregnant during the study and practicing appropriate birth control such as oral contraceptives (for at least 60 days ), implants, intrauterine contraceptive devices, sexual abstinence, tubal ligation, or a vasectomized partner, for the study duration
- Signed written informed consent.
- Willing and able to comply with study procedures (including reporting to the research center for all weekday evening administrations and staying overnight in the research facility for required PK samplings
Who cannot join
- Has a known intolerance, sensitivity or any contraindication to Betahistine or Olanzapine, as delineated in product label
- Requires chronic or as needed use of systemic antihistamines, anti-obesity agents or psychoactive drugs .
- Has had a significant body weight loss of over 4 kg in the 90 days prior to screening.
- Has recently started a smoking cessation program.
- Has screening ESS score of over 6.
- Has personal history of gestational diabetes, or has a first degree relative with diabetes.
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- Has any clinically significant abnormality at screening, as judged by Investigator, in laboratory test values (chemistry, hematology, metabolic or urinalysis), including Fasting blood glucose level over 110 mg/dL or HBA1c over 6.0% at screening. Renal insufficiency defined as a serum creatinine over 1.5 mg/dL (133 µmol/L) at screening; Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2 ULN; Triglycerides [TG] >200 mg/dL or low-density lipoprotein cholesterol [LDL-C] >190 mg/dL), Thyroid-stimulating hormone (TSH) outside of the normal range;
- Has any clinically significant abnormality in physical examination or electrocardiogram (ECG), as judged by the Investigator
- Has a clinically significant history or presence of any disease or unstable medical condition that might be affected by enrollment to this trial, as judged by the Investigator, including; Cardiovascular or cerebrovascular disease Diabetes mellitus (type 1 or 2); Malignant disease within 5 years of screening; Polycystic ovary disease; Hypertension (sitting blood pressure >140/90 mmHg at screening or randomization), History of asthma symptoms in the past 5 years; History of peptic ulcers in the past 5 years; History of HIV, Hepatitis B or Hepatitis C
- Plans on having any surgery (elective or otherwise) during the course of the study;
- Has received any investigational drug within 90 days prior to screening.
- Has been treated over the past 60 days, is currently treated, or is expected to require or undergo treatment with any medications for a period of more than 3 days (with the exception of antibiotic treatment for a period of less than 7 days).
- Is an immediate family member of personnel directly affiliated with the study at the investigative site, or is personally directly affiliated with the study at the investigative site; or is employed by OBEcure Ltd.
Trial locations and contacts
2 sites in 1 country.
Romania2 sites
Pierrel Research HP-RO
Arad
Pierrel Research HP-RO
Timișoara, RO-300244
About this study
Official title: Evaluation of Safety, Drug-Drug Interactions and Pharmacokinetic Profiles of Co-Administration of Escalating Doses of Extended Release and Standard Formulations of Betahistine as Monotherapy and as Adjunctive to Olanzapine in Healthy Subjects
The study aims to evaluate the safety and pharmacokinetics of extended release and standard formulations of betahistine when administered as monotherapy and as compared to their safety and pharmacokinetics when co-administered with olanzapine and to determine potential dose limiting toxicities and/or drug-drug interactions affecting the pharmacokinetics or safety of either medication, with particular emphasis on somnolence and weight gain secondary to olanzapine treatment
- Conditions
- Healthy
- Being tested
- Betahistine standard formulation, Betahistine Extended Release formulation, Placebo
- Keywords
- betahistine olanzapine weight sleepiness, olanzapine induced weight gain and sleepiness
- Medical subject headings
- Sleepiness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Betahistine standard formulationDrug
betahistine 24 mg tablets
Betahistine Extended Release formulationDrug
betahistine 32 mg tablets
PlaceboDrug
matching placebo
| Study group | Role | What they receive |
|---|---|---|
| betahistine | Experimental | Betahistine 24 mg tablets Receives: Drug: Betahistine standard formulation |
| betahistine XR | Experimental | betahistine 32 mg tablets Receives: Drug: Betahistine Extended Release formulation |
| placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of safety of escalating doses of extended release and standard formulations of betahistine, as monotherapy and as adjunctive to olanzapine
The total expected duration of the study for each subject will be 7 weeks. Total exposure time to Betahistine alone will be 1 week and total exposure time to Betahistine plus Olanzapine will be 3 weeks.
Measured: thisoutcome will be assssed 7 weeks after radomization.
Evaluation of drug-drug interactions and pharmacokinetic profiles of escalating doses of extended release and standard formulations of betahistine, as adjunctive to olanzapine
Measured: 4 weeks
Evaluation of pharmacokinetic profiles of escalating doses of extended release and standard formulations of betahistine, as monotherapy and as adjunctive to olanzapine
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2010 (estimated)
- Study startJul 2010
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- OBEcure Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Rodica Cinca, Prof MD, Principal investigator, Pierrel Research HP-RO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01168336
- Sponsor's protocol ID
- BET 216
- Status last verified
- Dec 2010
- First submitted
- 20 Jul 2010
- Last updated
- 30 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Safety, Drug-Drug Interactions and Pharmacokinetic Profiles of Co-Administration of Escalating Doses of Extended Release and Standard Formulations of Betahistine as Monotherapy and as Adjunctive to Olanzapine in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01168336
- Acronym / sponsor ID
- BET 216
- Conditions
- Healthy
- Keywords
- betahistine olanzapine weight sleepiness, olanzapine induced weight gain and sleepiness
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- OBEcure Ltd.Industry (pharma, biotech, devices)
- Study start
- Jul 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 23 Jul 2010 (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 study aims to evaluate the safety and pharmacokinetics of extended release and standard formulations of betahistine when administered as monotherapy and as compared to their safety and pharmacokinetics when co-administered with olanzapine and to determine potential dose limiting toxicities and/or drug-drug interactions affecting the pharmacokinetics or safety of either medication, with particular emphasis on somnolence and weight gain secondary to olanzapine treatment
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| betahistine | Experimental | Drug: Betahistine standard formulationBetahistine 24 mg tablets |
| betahistine XR | Experimental | Drug: Betahistine Extended Release formulationbetahistine 32 mg tablets |
| placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy subjects 18 to 45 years of age and Body Mass Index (BMI)in the range of 18.5 to 27.0
- Male and females
- If female - must be non-lactating and non-pregnant, as measured by negative urine pregnancy test, have no plans to become pregnant during the study and practicing appropriate birth control such as oral contraceptives (for at least 60 days ), implants, intrauterine contraceptive devices, sexual abstinence, tubal ligation, or a vasectomized partner, for the study duration
- Signed written informed consent.
- Willing and able to comply with study procedures (including reporting to the research center for all weekday evening administrations and staying overnight in the research facility for required PK samplings
Key exclusion criteria (13 listed)
- Has a known intolerance, sensitivity or any contraindication to Betahistine or Olanzapine, as delineated in product label
- Requires chronic or as needed use of systemic antihistamines, anti-obesity agents or psychoactive drugs .
- Has had a significant body weight loss of over 4 kg in the 90 days prior to screening.
- Has recently started a smoking cessation program.
- Has screening ESS score of over 6.
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 |
|---|---|---|
| Betahistine standard formulationbetahistine 24 mg tablets | Drug | betahistine |
| Betahistine Extended Release formulationbetahistine 32 mg tablets | Drug | betahistine XR |
| Placebomatching placebo | Drug | placebo |
Primary outcome
Evaluation of safety of escalating doses of extended release and standard formulations of betahistine, as monotherapy and as adjunctive to olanzapine
Time frame: thisoutcome will be assssed 7 weeks after radomization.
The total expected duration of the study for each subject will be 7 weeks. Total exposure time to Betahistine alone will be 1 week and total exposure time to Betahistine plus Olanzapine will be 3 weeks.
Evaluation of drug-drug interactions and pharmacokinetic profiles of escalating doses of extended release and standard formulations of betahistine, as adjunctive to olanzapine
Time frame: 4 weeks
Evaluation of pharmacokinetic profiles of escalating doses of extended release and standard formulations of betahistine, as monotherapy and as adjunctive to olanzapine
Time frame: 4 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 30 Dec 2010.
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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.
Rodica Cinca, Prof MD principal investigator
Pierrel Research HP-RO
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Betahistine standard formulation and Betahistine Extended Release formulation in people with Healthy, run by OBEcure Ltd. at 2 sites in Romania.
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 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 30 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Romania. 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. Some participants in this study may receive a placebo. 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?
Evaluation of safety of escalating doses of extended release and standard formulations of betahistine, as monotherapy and as adjunctive to olanzapine (time frame: thisoutcome will be assssed 7 weeks after radomization.). The study lists 3 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 30 Dec 2010.