A Study to Evaluate How VI-0521 Affect Psychomotor Performance in Healthy Overweight and Obese Subjects.
A Phase 2, Randomized, Double-blind, Placebo-controlled, Cross-over Study to Evaluate the Psychomotor Effect of VI-0521 in Healthy Overweight and Obese Subjects.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
-
-
Nebraska
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Lincoln, Nebraska, Forenede Stater, 68502
- Research Site
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Written consents;
- Adequate contraception from screening through 28 days after the last dose of study drug for female subjects;
- Healthy obese or overweight subjects with BMI between 27 and 35.
Exclusion Criteria:
- History of glaucoma or any past or present use of medications to treat increased intraocular pressure;
- Current use of any tobacco products, including cigarettes, cigars, pipes, or chewing tobacco, or use within the three months prior to screening;
- History of drug abuse during the three years prior to screening;
- History of alcohol abuse, or excessive alcohol consumption, or describes themselves as non-users of alcohol;
- Current depression of moderate or greater severity, or any presence or history of suicidal behavior or active suicidal ideation
- More than one lifetime episode of major depression;
- Currently working night shifts at a job;
- On average consumes greater than two cups of coffee or xanthine-containing beverages per day (>200 mg/day) within the two weeks prior to screening;
- Any use of dietary, herbal, and/or fitness/body-building supplements (with the exception of vitamins) within one month prior to screening;
- Aspartate aminotransferase or alanine aminotransferase >2.5 x ULN;
- Serum creatinine ≥1.5 mg/dL for men or ≥1.4 mg/dL for women.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Treatment 1
Dosed first with alcohol, then active VI-0521, and last, VI-0521 placebo
|
Placebo dagligt i 4 uger
Phentermine 3.75 mg and topiramate 23 mg daily for the 1st week; Phentermine 7.5 mg and topiramate 46 mg daily for the 2nd week; Phentermine 11.25 mg and topiramate 69 mg daily for the 3rd week; Phentermine 15 mg and topiramate 92 mg daily for the 4th week
|
|
Eksperimentel: Treatment 2
First dosed with alcohol placebo (fruit juice), then active VI-0521, and last, placebo VI-0521
|
Placebo dagligt i 4 uger
Phentermine 3.75 mg and topiramate 23 mg daily for the 1st week; Phentermine 7.5 mg and topiramate 46 mg daily for the 2nd week; Phentermine 11.25 mg and topiramate 69 mg daily for the 3rd week; Phentermine 15 mg and topiramate 92 mg daily for the 4th week
fruit juice
|
|
Eksperimentel: Treatment 3
First dosed with alcohol, then VI-0521 placebo, and last, active VI-0521
|
Placebo dagligt i 4 uger
Phentermine 3.75 mg and topiramate 23 mg daily for the 1st week; Phentermine 7.5 mg and topiramate 46 mg daily for the 2nd week; Phentermine 11.25 mg and topiramate 69 mg daily for the 3rd week; Phentermine 15 mg and topiramate 92 mg daily for the 4th week
|
|
Eksperimentel: Treatment 4
First dosed with alcohol placebo, then VI-0521 placebo, and last, active VI-0521
|
Placebo dagligt i 4 uger
Phentermine 3.75 mg and topiramate 23 mg daily for the 1st week; Phentermine 7.5 mg and topiramate 46 mg daily for the 2nd week; Phentermine 11.25 mg and topiramate 69 mg daily for the 3rd week; Phentermine 15 mg and topiramate 92 mg daily for the 4th week
fruit juice
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Measure of Psychomotor Function Using Speed and Coordination on the CogScreen Pathfinder Number (PFN) Test in Subjects Treated With Alcohol Compared to Alcohol Placebo in Period 1.
Tidsramme: at breath alcohol levels 0.10%, 0.07%, and 0.04%
|
CogScreen-Psychomotor Edition (CogScreen-PM) consists of a series of computerized cognitive tasks, each self-contained and presented with instructions and a practice segment. The test battery takes about 20-25 minutes to perform. Performance on the test will be measured as the median reaction time for correct responses (PFNRTC) and coordination errors (PFNCOOR) before and after treatment. The measures of the tests are: (a) response speed, the median response time to complete each sequential step (PFNRTC); (b) response accuracy (PF Number Accuracy [PFNACC]); and (c) a coordination measure indicating the respondent's proximity to the center of the target numbers and letters (PF Number Coordination [PFNCOOR]). PF measures number sequencing skills, immediate memory, psychomotor speed and coordination, and visual scanning. The normal range for PFN scores is 1.17-2.16. Scores that are higher than this range indicate some level of psychomotor impairment. |
at breath alcohol levels 0.10%, 0.07%, and 0.04%
|
|
Measure of Psychomotor Function Using Speed and Coordination on the CogScreen Pathfinder Number (PFN) Test in Subjects Treated With VI-0521 Compared to Placebo in Periods 2 and 3.
Tidsramme: Hour 2 and Hour 6
|
CogScreen-Psychomotor Edition (CogScreen-PM) consists of a series of computerized cognitive tasks, each self-contained and presented with instructions and a practice segment. The test battery takes about 20-25 minutes to perform. Performance on the test will be measured as the median reaction time for correct responses (PFNRTC) and coordination errors (PFNCOOR) before and after treatment. The measures of the tests are: (a) response speed, the median response time to complete each sequential step (PFNRTC); (b) response accuracy (PF Number Accuracy [PFNACC]); and (c) a coordination measure indicating the respondent's proximity to the center of the target numbers and letters (PF Number Coordination [PFNCOOR]). PF measures number sequencing skills, immediate memory, psychomotor speed and coordination, and visual scanning. The normal range for PFN scores is 1.17-2.16. Scores that are higher than this range indicate some level of psychomotor impairment. |
Hour 2 and Hour 6
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Alan Marion, MD, MDS Pharma Services
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- OB-205
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