Drug AbusePhase 1NCT02609477
A Study to Evaluate Abuse Potential of Istradefylline
A Phase 1 study testing Istradefylline and Phentermine 45 mg in people with Drug Abuse, run by Kyowa Kirin Co., Ltd. at 1 site in United States.
Trial summary
This study is to evaluate the abuse potential of single-doses of istradefylline compared to placebo and phentermine in recreational stimulant users. Subjects will participate in an outpatient medical Screening visit, a 5-day Qualification (Drug Discrimination) Phase, a 6-period Treatment Phase, and an outpatient… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Drug Abuse
- What is being tested?
- Istradefylline and Phentermine 45 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to Jul 2016
- 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
- Subjects who will provide written informed consent
- Healthy volunteer, male and female between 18 and 55 years of age, inclusive
- Subjects with a body mass index (BMI) within 18.0 to 33.0 kg/m2, inclusive
- Subjects who are recreational drug user
Who cannot join
- Subjects who have an alcohol or substance dependence within the 12 months
- Subjects who have ever been in treatment for substance use disorder
- Subjects who consume on average more than 5 servings of caffeinated beverages per day
- Subjects with a history of or presence of any clinically significant cardiovascular disease
- Subject with hyperthyroidism or glaucoma.
Trial locations and contacts
1 site in 1 country.
United States1 site
Pharmaceutical Research Associates, Inc
Salt Lake City, Utah, 84106
About this study
Official title: A Double-Blind, Randomized, Placebo- and Active-Controlled Crossover Study to Evaluate the Abuse Potential of Istradefylline in Recreational Drug Users
This study is to evaluate the abuse potential of single-doses of istradefylline compared to placebo and phentermine in recreational stimulant users. Subjects will participate in an outpatient medical Screening visit, a 5-day Qualification (Drug Discrimination) Phase, a 6-period Treatment Phase, and an outpatient safety Follow-Up visit. Study will be approximately 25 weeks total.
Within 28 days of the Screening visit, eligible subjects will be admitted to the CRU (Day -1) for the Qualification Phase. During the Qualification Phase, subjects will receive single oral doses of phentermine 60 mg and matching placebo in a randomized, double blind, crossover manner, with each drug administration separated by approximately 48 hours (Day 1 and Day 3), to ensure that they can discriminate and show positive subjective effects of the active controls. Following evaluation of eligibility, subjects may be discharged (those who fail Qualification criteria) or remain in the CRU (those who pass criteria and are eligible) and then proceed directly to the Treatment Phase. The washout interval between last drug administration in the Qualification Phase and first drug administration in the Treatment Phase will be at least 96 hours (4 days).
Read more
Following confirmation of eligibility from the Qualification Phase, subjects will be randomized to one of 6 treatment sequences according to a 6x6 Williams square. Subjects will receive single oral doses of each of the 6 treatments in a randomized, double-blind, crossover manner, Istradefylline 40 mg, Istradefylline 80 mg, Istradefylline 160 mg, Phentermine 45 mg, Phentermine 90 mg, Placebo.
Each drug administration will be separated by at least 21 days. Serial pharmacodynamic evaluations will be conducted up to 24 hours after each study drug administration to confirm exposure to istradefylline.
- Conditions
- Drug Abuse
- Being tested
- Istradefylline, Phentermine 45 mg, Placebo
- Keywords
- Recreational stimulant users, Recreational Drug Users
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IstradefyllineDrug
Also called 6002
Istradefylline 40, 80, 160 mg
Phentermine 45 mgDrug
Phentermine 45 or 90 mg
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Istradefylline 40 mg | Experimental | 40 mg istradefylline (1 × 40 mg tablet + 3 × placebo tablets + 3 × placebo capsules) Receives: Drug: Istradefylline; Other: Placebo |
| Istradefylline 80 mg | Experimental | 80 mg istradefylline (2 × 40 mg tablets + 2 × placebo tablets + 3 × placebo capsules) Receives: Drug: Istradefylline; Other: Placebo |
| Istradefylline 160 mg | Experimental | 160 mg istradefylline (4 × 40 mg tablets + 3 × placebo capsules) Receives: Drug: Istradefylline; Other: Placebo |
| Phentermine 45 mg | Active comparator | 45 mg phentermine (4 x placebo tablets + 3 × 15 mg phentermine hydrochloride capsules) Receives: Drug: Phentermine 45 mg; Other: Placebo |
| Phentermine 90 mg | Active comparator | 90 mg phentermine (4 × placebo tablets + 3 × 30 mg phentermine hydrochloride capsules) Receives: Drug: Phentermine 45 mg; Other: Placebo |
| Placebo | Placebo comparator | Placebo (4 × placebo tablets + 3 × placebo capsules) Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Drug Liking VAS
To evaluate the abuse potential of istradefylline compared to phentermine and placebo.
Measured: 24 hours
Secondary outcomes (5)
C-SSRS (Columbia Suicide Severity Rating Scale)
To evaluate the safety and tolerability of istradefylline.
Measured: 24 hours
Alerness/Drowsiness, Agitation/Relaxation VAS
To evaluate the safety and tolerability of istradefylline.
Measured: 24 hours
Caffine Withdrawal/Symptom Questionnaire
To evaluate the safety and tolerability of istradefylline.
Measured: 24 hours
Overall Drug Liking, Take Drug Again VAS
To evaluate the safety and tolerability of istradefylline.
Measured: 24 hours
Drug Similarity VAS
To evaluate the safety and tolerability of istradefylline.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2015 (estimated)
- Study startJan 2016
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug AbuseStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 42 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
- Kyowa Hakko Kirin Pharma, Inc., Study chair, Kyowa Hakko Kirin Pharma, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02609477
- Sponsor's protocol ID
- 6002-017
- Status last verified
- Aug 2016
- First submitted
- 13 Nov 2015
- 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
- A Double-Blind, Randomized, Placebo- and Active-Controlled Crossover Study to Evaluate the Abuse Potential of Istradefylline in Recreational Drug Users
- ClinicalTrials.gov ID
- NCT02609477
- Acronym / sponsor ID
- 6002-017
- Conditions
- Drug Abuse
- Keywords
- Recreational stimulant users, Recreational Drug Users
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Kyowa Kirin Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Kyowa Hakko Kirin Pharma, Inc.
- Study start
- Jan 2016
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 20 Nov 2015 (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 to evaluate the abuse potential of single-doses of istradefylline compared to placebo and phentermine in recreational stimulant users. Subjects will participate in an outpatient medical Screening visit, a 5-day Qualification (Drug Discrimination) Phase, a 6-period Treatment Phase, and an outpatient safety Follow-Up visit. Study will be approximately 25 weeks total.
Within 28 days of the Screening visit, eligible subjects will be admitted to the CRU (Day -1) for the Qualification Phase. During the Qualification Phase, subjects will receive single oral doses of phentermine 60 mg and matching placebo in a randomized, double blind, crossover manner, with each drug administration separated by approximately 48 hours (Day 1 and Day 3), to ensure that they can discriminate and show positive subjective effects of the active controls. Following evaluation of eligibility, subjects may be discharged (those who fail Qualification criteria) or remain in the CRU (those who pass criteria and are eligible) and then proceed directly to the Treatment Phase. The washout interval between last drug administration in the Qualification Phase and first drug administration in the Treatment Phase will be at least 96 hours (4 days).
Following confirmation of eligibility from the Qualification Phase, subjects will be randomized to one of 6 treatment sequences according to a 6x6 Williams square. Subjects will receive single oral doses of each of the 6 treatments in a randomized, double-blind, crossover manner, Istradefylline 40 mg, Istradefylline 80 mg, Istradefylline 160 mg, Phentermine 45 mg, Phentermine 90 mg, Placebo.
Each drug administration will be separated by at least 21 days. Serial pharmacodynamic evaluations will be conducted up to 24 hours after each study drug administration to confirm exposure to istradefylline.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Istradefylline 40 mg | Experimental | Drug: Istradefylline, Other: Placebo40 mg istradefylline (1 × 40 mg tablet + 3 × placebo tablets + 3 × placebo capsules) |
| Istradefylline 80 mg | Experimental | Drug: Istradefylline, Other: Placebo80 mg istradefylline (2 × 40 mg tablets + 2 × placebo tablets + 3 × placebo capsules) |
| Istradefylline 160 mg | Experimental | Drug: Istradefylline, Other: Placebo160 mg istradefylline (4 × 40 mg tablets + 3 × placebo capsules) |
| Phentermine 45 mg | Active comparator | Drug: Phentermine 45 mg, Other: Placebo45 mg phentermine (4 x placebo tablets + 3 × 15 mg phentermine hydrochloride capsules) |
| Phentermine 90 mg | Active comparator | Drug: Phentermine 45 mg, Other: Placebo90 mg phentermine (4 × placebo tablets + 3 × 30 mg phentermine hydrochloride capsules) |
| Placebo | Placebo comparator | Other: PlaceboPlacebo (4 × placebo tablets + 3 × placebo capsules) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Subjects who will provide written informed consent
- Healthy volunteer, male and female between 18 and 55 years of age, inclusive
- Subjects with a body mass index (BMI) within 18.0 to 33.0 kg/m2, inclusive
- Subjects who are recreational drug user
Key exclusion criteria (5 listed)
- Subjects who have an alcohol or substance dependence within the 12 months
- Subjects who have ever been in treatment for substance use disorder
- Subjects who consume on average more than 5 servings of caffeinated beverages per day
- Subjects with a history of or presence of any clinically significant cardiovascular disease
- Subject with hyperthyroidism or glaucoma.
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 |
|---|---|---|
| IstradefyllineAlso: 6002Istradefylline 40, 80, 160 mg | Drug | Istradefylline 160 mg, Istradefylline 40 mg, Istradefylline 80 mg |
| Phentermine 45 mgPhentermine 45 or 90 mg | Drug | Phentermine 45 mg, Phentermine 90 mg |
| PlaceboPlacebo | Other | Istradefylline 160 mg, Istradefylline 40 mg, Istradefylline 80 mg, Phentermine 45 mg, Phentermine 90 mg, Placebo |
Primary outcome
Drug Liking VAS
Time frame: 24 hours
To evaluate the abuse potential of istradefylline compared to phentermine and placebo.
5 secondary outcomes
C-SSRS (Columbia Suicide Severity Rating Scale)
Time frame: 24 hours
Alerness/Drowsiness, Agitation/Relaxation VAS
Time frame: 24 hours
Caffine Withdrawal/Symptom Questionnaire
Time frame: 24 hours
Overall Drug Liking, Take Drug Again VAS
Time frame: 24 hours
Drug Similarity VAS
Time frame: 24 hours
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.
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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.
Kyowa Hakko Kirin Pharma, Inc. study chair
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 and Phentermine 45 mg in people with Drug Abuse, 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 4 inclusion and 5 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. 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?
Drug Liking VAS (time frame: 24 hours). 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.