Parkinson's DiseasePhase 1NCT02174250
The Effect of Rifampin on the Metabolism of Istradefylline in Healthy Volunteers.
A Phase 1 study testing Istradefylline 40 mg and Rifampin 300mg BID + istradefylline 40mg Day 8 only in people with Parkinson's Disease, run by Kyowa Kirin Co., Ltd. at 1 site in United States.
Trial summary
The purpose of this study is to test whether Rifampin affects blood levels of istradefylline in humans. Rifampin could possibly decrease istradefylline levels. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Istradefylline 40 mg and Rifampin 300mg BID + istradefylline 40mg Day 8 only
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to Dec 2014
- 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy non-smoking male and post-menopausal female subjects
- Body Mass Index: 18.0-35.0 kg/m2, inclusive
- Subjects must not be taking drugs that are moderate to potent inhibitors of CYP3A4 or CYP1A2.
- Subjects without clinically significant medical history in the judgment of the investigator
- Subjects without clinically significant laboratory or ECG abnormalities
Who cannot join
- Females that are pregnant or lactating
- Administration of an investigational drug within 30 days or 5 elimination half-lives of such investigational drug, whichever is longer, prior to study drug administration, or planned administration of another investigational product or procedure during the subject's participation in this study;
- Known history of treatment for drug or alcohol addiction within the previous 12 months;
- Subjects with an average alcohol intake of more than 2 units per day or 14 units per week up to 48 hours prior to the istradefylline dose on Day 1. One unit of alcohol is ½ pint of beer (285 mL) or 1 glass of spirits (25 mL) or 1 glass of wine (125 mL);
- Donated or lost > 500 mL of blood within 3 months prior to istradefylline dose on Day 1 of Period 1;
- Positive test results for human immunodeficiency virus (HIV) or Hepatitis B surface antigen, or Hepatitis C;
Show all 10Show fewer
- Positive test results for drugs of abuse at screening;
- Unable, or unwilling to tolerate multiple venipunctures;
- Difficulty fasting or eating the standard meals that will be provided;
- Use of tobacco or nicotine-containing products within 90 days of the study start to the Follow-up visit
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of a Strong Enzyme Inducer, Rifampin, on the Single-Dose Pharmacokinetics of Istradefylline in Healthy Subjects
The purpose of this study is to test whether Rifampin affects blood levels of istradefylline in humans. Rifampin could possibly decrease istradefylline levels.
- Conditions
- Parkinson's Disease
- Being tested
- Istradefylline 40 mg, Rifampin 300mg BID + istradefylline 40mg Day 8 only
- Keywords
- PD
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Istradefylline 40 mgDrug
Also called KW-6002
On Day 1, istradefylline 1 × 40-mg tablet administered alone
Rifampin 300mg BID + istradefylline 40mg Day 8 onlyDrug
Also called rifadin
On Days 1 - 20, rifampin 300mg BID; On Day 8, istradefylline 40 mg administered first with rifampin about 2 hours after istradefylline administration
| Study group | Role | What they receive |
|---|---|---|
| Istradefylline 40mg | Experimental | Period 1: Day 1, istradefylline 40mg then crossover to Period 2 Receives: Drug: Istradefylline 40 mg |
| Rifampin 300mg BID + istradefylline 40mg | Experimental | Period 2: Days 1-20 rifampin 300mg BID + istradefylline 40mg Day 8 only Receives: Drug: Istradefylline 40 mg; Drug: Rifampin 300mg BID + istradefylline 40mg Day 8 only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the concentration-time curve from time zero to infinity (AUC0 ∞) and Observed maximum plasma concentration (Cmax) of istradefylline
Measured: Intermittently for a total of 62 days
Secondary outcomes (1)
Number of serious adverse events, and non-serious adverse events
Measured: Continuously for up to 74 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionAug 2014
- Study completionDec 2014
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.
- More trials run by Kyowa Kirin Co., Ltd.The 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyowa Kirin Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Kyowa Hakko Kirin Pharma, Inc.
- Responsible party
- Sponsor
- Investigators
- Marc Cantillon, M.D., Study chair, Kyowa Hakko Kirin Pharma, Inc.Amy Zhang, PhD, Study director, Kyowa Hakko Kirin Pharma, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02174250
- Sponsor's protocol ID
- 6002-015
- Status last verified
- Apr 2024
- First submitted
- 24 Jun 2014
- Last updated
- 25 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Strong Enzyme Inducer, Rifampin, on the Single-Dose Pharmacokinetics of Istradefylline in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02174250
- Acronym / sponsor ID
- 6002-015
- Conditions
- Parkinson's Disease
- Keywords
- PD
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Kyowa Kirin Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Kyowa Hakko Kirin Pharma, Inc.
- Study start
- Jun 2014
- Primary completion
- Aug 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 25 Jun 2014 (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 test whether Rifampin affects blood levels of istradefylline in humans. Rifampin could possibly decrease istradefylline levels.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Istradefylline 40mg | Experimental | Drug: Istradefylline 40 mgPeriod 1: Day 1, istradefylline 40mg then crossover to Period 2 |
| Rifampin 300mg BID + istradefylline 40mg | Experimental | Drug: Istradefylline 40 mg, Drug: Rifampin 300mg BID + istradefylline 40mg Day 8 onlyPeriod 2: Days 1-20 rifampin 300mg BID + istradefylline 40mg Day 8 only |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Healthy non-smoking male and post-menopausal female subjects
- Body Mass Index: 18.0-35.0 kg/m2, inclusive
- Subjects must not be taking drugs that are moderate to potent inhibitors of CYP3A4 or CYP1A2.
- Subjects without clinically significant medical history in the judgment of the investigator
- Subjects without clinically significant laboratory or ECG abnormalities
Key exclusion criteria (10 listed)
- Females that are pregnant or lactating
- Administration of an investigational drug within 30 days or 5 elimination half-lives of such investigational drug, whichever is longer, prior to study drug administration, or planned administration of another investigational product or procedure during the subject's participation in this study;
- Known history of treatment for drug or alcohol addiction within the previous 12 months;
- Subjects with an average alcohol intake of more than 2 units per day or 14 units per week up to 48 hours prior to the istradefylline dose on Day 1. One unit of alcohol is ½ pint of beer (285 mL) or 1 glass of spirits (25 mL) or 1 glass of wine (125 mL);
- Donated or lost > 500 mL of blood within 3 months prior to istradefylline dose on Day 1 of Period 1;
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 |
|---|---|---|
| Istradefylline 40 mgAlso: KW-6002On Day 1, istradefylline 1 × 40-mg tablet administered alone | Drug | Istradefylline 40mg, Rifampin 300mg BID + istradefylline 40mg |
| Rifampin 300mg BID + istradefylline 40mg Day 8 onlyAlso: rifadinOn Days 1 - 20, rifampin 300mg BID; On Day 8, istradefylline 40 mg administered first with rifampin about 2 hours after istradefylline administration | Drug | Rifampin 300mg BID + istradefylline 40mg |
Primary outcome
Area under the concentration-time curve from time zero to infinity (AUC0 ∞) and Observed maximum plasma concentration (Cmax) of istradefylline
Time frame: Intermittently for a total of 62 days
1 secondary outcome
Number of serious adverse events, and non-serious adverse events
Time frame: Continuously for up to 74 days
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 25 Apr 2024.
Related trials for Parkinson's Disease
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
Active, not recruitingPhase 1/2
Clinical Safety and Efficacy of Umbilical Cord Mesenchymal Stromal Cells-derived Exosomes in Patients With Parkinson's Disease
Parkinson Disease (PD)
Active, not recruitingObservational study
Adaptive DBS to Offset STN Dysregulation During Exercise in PD
Parkinson Disease
Not yet recruiting
Compulsive Eating and Brain's Reward System in Different Pathologies
PARKINSON DISEASE (Disorder), Bipolar 1 Disorder
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
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.
Marc Cantillon, M.D. study chair
Kyowa Hakko Kirin Pharma, Inc.
Amy Zhang, PhD study director
Kyowa Hakko Kirin Pharma, Inc.
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 Istradefylline 40 mg and Rifampin 300mg BID + istradefylline 40mg Day 8 only in people with Parkinson's Disease, run by Kyowa Kirin Co., Ltd. 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 5 inclusion and 10 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 25 Apr 2024. 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. 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?
Area under the concentration-time curve from time zero to infinity (AUC0 ∞) and Observed maximum plasma concentration (Cmax) of istradefylline (time frame: Intermittently for a total of 62 days). 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 25 Apr 2024.