Multiple-Ascending Dose Study

Placebo-Controlled, Ascending Multiple-Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BMS-820836 in Healthy Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00892840

Enrollment

Registered

2009-05-05

Start date

2009-05-31

Completion date

2010-11-30

Last updated

2011-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression

Brief summary

The purpose of this study is to determine the safety and tolerability of BMS-820836 after multiple doses

Interventions

DRUGBMS-820836

Oral Solution, Oral, 0.1 mg to 4 mg, Once daily, 14 days

DRUGPlacebo

Oral Solution, Oral, 0 mg, Once daily, 14 days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

21 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* Panels 1-6: Healthy Male Subjects * Panel 7: Females * Ages 21 to 55, inclusive * Body Mass Index (BMI) of 18 to 32 kg/m2, inclusive * Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations

Exclusion criteria

* Any major surgery within 4 weeks of study drug administration * History of cholecystectomy * History of glaucoma or a confirmed intraocular pressure indicative of glaucoma at screening. (Normal IOP \<21 mmHg) * Confirmed QTc (Fridericia) value ≥ 450 msec * Confirmed QT ≥ 500 msec * Confirmed PR ≥ 210 msec * Confirmed QRS ≥ 120 msec * Confirmed resting supine systolic blood pressure \> 140 mmHg * Confirmed resting supine diastolic blood pressure \> 90 mmHg * Confirmed resting heart rate \< 45 bpm or \> 100 bpm * Orthostatic vital sign changes (ie., a decrease in systolic blood pressure from supine to standing \> 40 mmHg and an increase in heart rate from supine to standing \> 20 bpm) or symptoms of orthostasis * History of peppermint allergies * Exposure to any investigational drug or placebo within 12 weeks of study drug administration

Design outcomes

Primary

Measure	Time frame
To assess the safety and tolerability of BMS-820836 following multiple-dose administration	Within 27 days (+/- 2 days) of first dose

Secondary

Measure	Time frame
To assess the pharmacodynamics of BMS-820836	Within 27 days of first dose

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 19, 2026