Parkinson's DiseasePhase 1NCT01879748
A Study to Assess the Pharmacokinetics, Safety, and Tolerability of Single and Multiple Doses of Rasagiline
A Phase 1 study testing Rasagiline in people with Parkinson's Disease, run by Teva Branded Pharmaceutical Products R&D, Inc. at 1 site in United States.
Trial summary
This study is designed to evaluate the pharmacokinetics of rasagiline in healthy Japanese and Caucasian subjects after single and multiple doses of rasagiline. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Rasagiline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to Nov 2013
- 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 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- The subject is able to read, speak, and write in English or Japanese, as applicable.
- The subject is able to understand and be willing to comply with the study requirements (eg, all dietary, exercise, tobacco, and alcohol restrictions) and provide written informed consent to participate in the study.
- The subject is a man or woman, 20 to 50 years of age, inclusive.
- The subject has a body mass index (BMI) of 18.0-28.0 kg/m2, inclusive.
- The subject is in a good health, as determined by medical history, ECG, vital signs, physical examination, and clinical laboratory tests.
- If female and of childbearing potential, the subject must have a negative β-hCG test at screening and a negative urine human chorionic gonadotropin (HCG) test at check-in and be willing and able to use one of the following medically acceptable double barrier methods of birth control from the screening visit through the end-of-study visit: non-hormonal intrauterine device with condom, diaphragm with condom, or condom with spermicide. Female subjects who are postmenopausal (1 year since last menses) must have elevated follicle stimulating hormone (FSH) level above 35 U/L, or be surgically sterile.
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- The subject must complete the screening process within 4 weeks before study drug administration.
- The subject must be willing and able to comply with study restrictions and to remain at the clinic for the required duration during the study period, and willing to return to the clinic for the follow-up evaluation, as specified in this protocol.
- Additional inclusion criteria for Japanese subjects:
- The subject was born in Japan and holds a valid Japanese passport.
- The subject has 2 Japanese parents and 4 Japanese grandparents, as confirmed by interview.
- The subject has been living outside of Japan for 10 years or fewer as confirmed by interview.
- Additional inclusion criterion for Caucasian subjects:
- The subject has no parents or grandparents of Japanese descent as confirmed by interview.
Who cannot join
- The subject is a woman who is pregnant or lactating.
- The subject has significant food or drug allergies or a known allergy or sensitivity to rasagiline or its derivatives or the formulation excipients.
- The subject is unwilling to refrain from vigorous exercise (eg, strenuous or unaccustomed weight lifting, running, bicycling, etc) from 7 days before the first day of study drug administration until the final assessment.
- The subject has had 1 of the following conditions in the noted amount of time before screening or at any time between screening and the first day of study drug administration:
- major trauma or surgery in the last 2 months
- acute infection in the last 2 weeks
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- malignancy within the last 5 years
- The subject has a history of tuberculosis.
- The subject has any condition that may interfere with drug absorption, distribution, metabolism, or excretion.
- The subject is suffering from, or has a clinically significant history of, 1 or more of the following: cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, neurological, immunological, or psychiatric disorder(s), or a history of any illness that, in the opinion of the investigator, might confound the results of the study or pose additional risk to the subject if he or she participates in the study.
- The subject has a positive test for hepatitis B surface antigen (HBsAg), hepatitis C antibody, or human immunodeficiency virus (HIV) antibody.
- The subject has a history of hypertension or occasional increase of blood pressure, or any history of vascular structural abnormality.
- The subject has a sitting blood pressure outside the range of 80 to 139 mm Hg (systolic) or 45 to 89 mm Hg (diastolic) (after at least a 5-minute rest) measured at screening. Blood pressure may be retested twice at intervals of 5 minutes. The blood pressure is considered sustained if either the systolic or diastolic pressure exceeds the stated limits in all 3 assessments.
- The subject has used 1 of the following prohibited drugs or foods:
- an investigational drug (new chemical entity) during the month prior to the first day of study drug administration
- antidepressants, including selective serotonin reuptake inhibitors, tricyclic and tetracyclic antidepressants, within 42 days before the first day of study drug administration
- MAO inhibitors, including reserpine and methyldopa, within 3 months prior to the first day of study drug administration
- any medications (including over-the-counter [OTC] medications, vitamins, or herbal or nutritional supplements) within 14 days before the first day of study drug administration (except paracetamol/acetaminophen or ibuprofen used occasionally, up to 24 hours before the first day of study drug administration)
- drugs known to significantly inhibit CYP1A enzyme drug metabolism within 14 days before the first day of study drug administration or drugs known to significantly induce human cytochrome P enzyme (CYP)1A drug metabolism within 28 days before the first day of study drug administration
- excessive amounts of alcohol, defined as more than 3 drinks of alcoholic beverages (eg, beer, wine, or distilled spirits) per day in the last 3 months before the first day of study drug administration or a history of alcohol abuse
- excessive amounts (equivalent to more than 6 cups of brewed coffee per day) of coffee, tea, cola, or other caffeinated beverages in the 3 months before the first day of study drug administration
- grapefruit, Seville oranges, pomelo, or products made from them within 14 days before the first day of study drug administration until after the last day of pharmacokinetic sampling.
- Other exclusion criteria apply.
Trial locations and contacts
1 site in 1 country.
United States1 site
Teva Investigational Site 10738
Glendale, California
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Study to Assess the Pharmacokinetics, Safety, and Tolerability of Single and Multiple Doses (0.5, 1.0, and 2.0 mg) of Rasagiline Administered to Healthy Japanese and Caucasian Subjects
This study is designed to evaluate the pharmacokinetics of rasagiline in healthy Japanese and Caucasian subjects after single and multiple doses of rasagiline.
Read the detailed description
This is a single-center, double-blind, placebo-controlled, randomized study in healthy Japanese and Caucasian subjects after administration of single and multiple doses of rasagiline. All subjects will have a screening visit within 28 days of their check-in day (day -1) to confirm eligibility. Eligible subjects will be admitted to the investigational center on study day -1 and their eligibility to participate in the study confirmed. On the morning of day 1, subjects will be randomly assigned to receive a daily dose of 0.5, 1, or 2 mg of rasagiline or placebo at the same time every morning after an overnight fast (of at least 10 hours) on days 1 through 10. Venous blood samples (4 mL each) for pharmacokinetic analysis will be collected at specified time points through 24 hours after study drug administration on day 1 and through 48 hours after study drug administration on day 10. The duration of study participation for each subject will be approximately 6 weeks.
- Conditions
- Parkinson's Disease
- Being tested
- Rasagiline, Placebo
- Keywords
- Parkinson's disease, Azilect, rasagiline mesylate
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RasagilineDrug
Also called rasagiline mesylate, TVP1012, AZILECT®
Each subject will be enrolled into 1 of 4 cohorts:
- cohort 1 (16 Japanese subjects): 4 subjects each for 0.5, 1, and 2 mg of rasagiline and placebo
- cohort 2 (16 Caucasian subjects): 4 subjects each for 0.5, 1, and 2 mg of rasagiline and placebo
- cohort 3 (16 Japanese subjects): 4 subjects each for 0.5, 1, and 2 mg of rasagiline and placebo
- cohort 4 (16 Caucasian subjects): 4 subjects each for 0.5, 1, and 2 mg of rasagiline and placebo
Each subject will then be randomly assigned to 1 of the following groups:
- rasagiline at 0.5 mg (8 Japanese and 8 Caucasian subjects)
- rasagiline at 1 mg (8 Japanese and 8 Caucasian subjects)
- rasagiline at 2 mg (8 Japanese and 8 Caucasian subjects)
- placebo (8 Japanese and 8 Caucasian subjects)
PlaceboDrug
Each subject will be enrolled into 1 of 4 cohorts:
- cohort 1 (16 Japanese subjects): 4 subjects each for 0.5, 1, and 2 mg of rasagiline and placebo
- cohort 2 (16 Caucasian subjects): 4 subjects each for 0.5, 1, and 2 mg of rasagiline and placebo
- cohort 3 (16 Japanese subjects): 4 subjects each for 0.5, 1, and 2 mg of rasagiline and placebo
- cohort 4 (16 Caucasian subjects): 4 subjects each for 0.5, 1, and 2 mg of rasagiline and placebo
Each subject will then be randomly assigned to 1 of the following groups:
- rasagiline at 0.5 mg (8 Japanese and 8 Caucasian subjects)
- rasagiline at 1 mg (8 Japanese and 8 Caucasian subjects)
- rasagiline at 2 mg (8 Japanese and 8 Caucasian subjects)
- placebo (8 Japanese and 8 Caucasian subjects)
| Study group | Role | What they receive |
|---|---|---|
| Rasagiline | Experimental | Rasagiline mesylate oral tablets (AZILECT®) are provided at dose strengths of 0.5 and 1 mg (based on rasagiline base). Rasagiline oral tablets will be dispensed for 10 consecutive days of treatment. The oral dose will be administered each day with 240 mL water at room temperature after an overnight fast of at least 10 hours. Receives: Drug: Rasagiline |
| Placebo | Placebo comparator | Placebo tablets match in size and appearance to rasagiline tablets for each dose strength. Placebo tablets will be dispensed for 10 consecutive days of treatment. The oral dose will be administered each day with 240 mL water at room temperature after an overnight fast of at least 10 hours. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Measured: At Baseline through Day 10
Tmax
Measured: At Baseline through Day 10
AUC from time 0 to the time of the last measurable drug concentration (AUC0-t)
AUC 0-t will be calculated after administration of a single dose of rasagiline.
Measured: At Baseline to Day 1
AUC from time 0 to infinity (AUC∞)
AUC∞ will be calculated after administration of a single dose of rasagiline.
Measured: At Baseline to Day 1
Percentage extrapolated AUC (%AUCext)
%AUCext will be calculated after administration of a single dose of rasagiline.
Measured: At Baseline to Day 1
Apparent plasma terminal elimination rate constant (λz)
Measured: At Baseline to Day 10
Associated elimination half life (t½)
Measured: At Baseline to Day 10
AUC over the dosing interval at steady state (AUCτ)
Measured: At Baseline to Day 10
Minimum measured plasma concentration at steady state by inspection (Cmin,ss)
minimum measured plasma concentration at steady state by inspection (Cmin,ss) (multiple dose [predose concentrations on days 8 and 9]))
Measured: From Baseline to Day 10
Average plasma concentration at steady state (Cav,ss)
The average plasma concentration at steady state (Cav,ss) is obtained by the calculation:
AUCτ/τ, where tau is the dosing interval
Measured: From Baseline to Day 10
Fluctuation at steady state
Fluctuation at steady state, calculated as (Cmax,ss-Cmin,ss)/Cav,ss
Measured: From Baseline to Day 10
Steady-state accumulation ratio (Rss)
Steady-state accumulation ratio (Rss) calculated as (AUCτ/AUC∞)
Measured: From Baseline to Day 10
Apparent total body clearance (CL/F)
Measured: From Baseline to Day 10
Apparent total volume of distribution (V/F)
Measured: From Baseline to Day 10
Secondary outcomes (3)
Concentrations of 1-aminoindan
The concentrations of rasagiline major metabolite, 1-aminoindan, in plasma will be calculated, if possible.
Measured: Day 1 to Day 11
Peripheral monoamine oxidase B (MAOB)
The pharmacodynamics of rasagiline will be assessed by measuring the extent of peripheral monoamine oxidase B (MAOB) inhibition after multiple-dose administration of rasagiline, calculated as the percentage of the baseline platelet MAO-B activity.
Measured: Day 1 to Day 11
Occurrence of Adverse Events
Adverse events, clinical laboratory test results, vital signs measurements, physical examinations, 12- lead electrocardiogram (ECG) findings, and use of concomitant medications will be assessed throughout the study.
Measured: From informed consent signing to end of study (Day 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionSep 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01879748
- Sponsor's protocol ID
- TVP1012-PK-10002
- Status last verified
- Dec 2013
- First submitted
- 13 Jun 2013
- Last updated
- 20 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Study to Assess the Pharmacokinetics, Safety, and Tolerability of Single and Multiple Doses (0.5, 1.0, and 2.0 mg) of Rasagiline Administered to Healthy Japanese and Caucasian Subjects
- ClinicalTrials.gov ID
- NCT01879748
- Acronym / sponsor ID
- TVP1012-PK-10002
- Conditions
- Parkinson's Disease
- Keywords
- Parkinson's disease, Azilect, rasagiline mesylate
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2013
- Primary completion
- Sep 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 18 Jun 2013 (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.
This study is designed to evaluate the pharmacokinetics of rasagiline in healthy Japanese and Caucasian subjects after single and multiple doses of rasagiline.
Detailed description
This is a single-center, double-blind, placebo-controlled, randomized study in healthy Japanese and Caucasian subjects after administration of single and multiple doses of rasagiline. All subjects will have a screening visit within 28 days of their check-in day (day -1) to confirm eligibility. Eligible subjects will be admitted to the investigational center on study day -1 and their eligibility to participate in the study confirmed. On the morning of day 1, subjects will be randomly assigned to receive a daily dose of 0.5, 1, or 2 mg of rasagiline or placebo at the same time every morning after an overnight fast (of at least 10 hours) on days 1 through 10. Venous blood samples (4 mL each) for pharmacokinetic analysis will be collected at specified time points through 24 hours after study drug administration on day 1 and through 48 hours after study drug administration on day 10. The duration of study participation for each subject will be approximately 6 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rasagiline | Experimental | Drug: RasagilineRasagiline mesylate oral tablets (AZILECT®) are provided at dose strengths of 0.5 and 1 mg (based on rasagiline base). Rasagiline oral tablets will be dispensed for 10 consecutive days of treatment. The oral dose will be administered each day with 240 mL water at room temperature after an overnight fast of at least 10 hours. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo tablets match in size and appearance to rasagiline tablets for each dose strength. Placebo tablets will be dispensed for 10 consecutive days of treatment. The oral dose will be administered each day with 240 mL water at room temperature after an overnight fast of at least 10 hours. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- The subject is able to read, speak, and write in English or Japanese, as applicable.
- The subject is able to understand and be willing to comply with the study requirements (eg, all dietary, exercise, tobacco, and alcohol restrictions) and provide written informed consent to participate in the study.
- The subject is a man or woman, 20 to 50 years of age, inclusive.
- The subject has a body mass index (BMI) of 18.0-28.0 kg/m2, inclusive.
- The subject is in a good health, as determined by medical history, ECG, vital signs, physical examination, and clinical laboratory tests.
Key exclusion criteria (23 listed)
- The subject is a woman who is pregnant or lactating.
- The subject has significant food or drug allergies or a known allergy or sensitivity to rasagiline or its derivatives or the formulation excipients.
- The subject is unwilling to refrain from vigorous exercise (eg, strenuous or unaccustomed weight lifting, running, bicycling, etc) from 7 days before the first day of study drug administration until the final assessment.
- The subject has had 1 of the following conditions in the noted amount of time before screening or at any time between screening and the first day of study drug administration:
- The subject has a history of tuberculosis.
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 |
|---|---|---|
| RasagilineAlso: rasagiline mesylate, TVP1012, AZILECT®Each subject will be enrolled into 1 of 4 cohorts: * cohort 1 (16 Japanese subjects): 4 subjects each for 0.5, 1, and 2 mg of rasagiline and placebo * cohort 2 (16 Caucasian subjects): 4 subjects each for 0.5, 1, and 2 mg of rasagiline and placebo * cohort 3 (16 Japanese subjects): 4 subjects each for 0.5, 1, and 2 mg of rasagiline and placebo * cohort 4 (16 Caucasian subjects): 4 subjects each for 0.5, 1, and 2 mg of rasagiline and placebo Each subject will then be randomly assigned to 1 of the following groups: * rasagiline at 0.5 mg (8 Japanese and 8 Caucasian subjects) * rasagiline at 1 mg (8 Japanese and 8 Caucasian subjects) * rasagiline at 2 mg (8 Japanese and 8 Caucasian subjects) * placebo (8 Japanese and 8 Caucasian subjects) | Drug | Rasagiline |
| PlaceboEach subject will be enrolled into 1 of 4 cohorts: * cohort 1 (16 Japanese subjects): 4 subjects each for 0.5, 1, and 2 mg of rasagiline and placebo * cohort 2 (16 Caucasian subjects): 4 subjects each for 0.5, 1, and 2 mg of rasagiline and placebo * cohort 3 (16 Japanese subjects): 4 subjects each for 0.5, 1, and 2 mg of rasagiline and placebo * cohort 4 (16 Caucasian subjects): 4 subjects each for 0.5, 1, and 2 mg of rasagiline and placebo Each subject will then be randomly assigned to 1 of the following groups: * rasagiline at 0.5 mg (8 Japanese and 8 Caucasian subjects) * rasagiline at 1 mg (8 Japanese and 8 Caucasian subjects) * rasagiline at 2 mg (8 Japanese and 8 Caucasian subjects) * placebo (8 Japanese and 8 Caucasian subjects) | Drug | Placebo |
Primary outcome
Cmax
Time frame: At Baseline through Day 10
Tmax
Time frame: At Baseline through Day 10
AUC from time 0 to the time of the last measurable drug concentration (AUC0-t)
Time frame: At Baseline to Day 1
AUC 0-t will be calculated after administration of a single dose of rasagiline.
AUC from time 0 to infinity (AUC∞)
Time frame: At Baseline to Day 1
AUC∞ will be calculated after administration of a single dose of rasagiline.
Percentage extrapolated AUC (%AUCext)
Time frame: At Baseline to Day 1
%AUCext will be calculated after administration of a single dose of rasagiline.
Apparent plasma terminal elimination rate constant (λz)
Time frame: At Baseline to Day 10
Associated elimination half life (t½)
Time frame: At Baseline to Day 10
AUC over the dosing interval at steady state (AUCτ)
Time frame: At Baseline to Day 10
Minimum measured plasma concentration at steady state by inspection (Cmin,ss)
Time frame: From Baseline to Day 10
minimum measured plasma concentration at steady state by inspection (Cmin,ss) (multiple dose [predose concentrations on days 8 and 9]))
Average plasma concentration at steady state (Cav,ss)
Time frame: From Baseline to Day 10
The average plasma concentration at steady state (Cav,ss) is obtained by the calculation: AUCτ/τ, where tau is the dosing interval
Fluctuation at steady state
Time frame: From Baseline to Day 10
Fluctuation at steady state, calculated as (Cmax,ss-Cmin,ss)/Cav,ss
Steady-state accumulation ratio (Rss)
Time frame: From Baseline to Day 10
Steady-state accumulation ratio (Rss) calculated as (AUCτ/AUC∞)
Apparent total body clearance (CL/F)
Time frame: From Baseline to Day 10
Apparent total volume of distribution (V/F)
Time frame: From Baseline to Day 10
3 secondary outcomes
Concentrations of 1-aminoindan
Time frame: Day 1 to Day 11
Peripheral monoamine oxidase B (MAOB)
Time frame: Day 1 to Day 11
Occurrence of Adverse Events
Time frame: From informed consent signing to end of study (Day 12)
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 20 Dec 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Rasagiline in people with Parkinson's Disease, run by Teva Branded Pharmaceutical Products R&D, Inc. at 1 site in United States.
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 14 inclusion and 23 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 20 Dec 2013. 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 United States. 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?
Cmax (time frame: At Baseline through Day 10). The study lists 14 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 20 Dec 2013; AzTrials last refreshed its copy on 6 Nov 2026.