Status:
COMPLETED
Safety & Tolerability of a Combination of Antidepressant and Peptic Ulcer Drug in Overweight Healthy Subjects
Lead Sponsor:
Theracos
Conditions:
Obesity
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
The hypothesis of this study is that up to 150 mg of sertraline and up to 3 mg of telenzepine will be safe, tolerable, and have the effect of suppressing appetite, when taken in combination daily by m...
Eligibility Criteria
Inclusion
- In good health based on medical history, physical examination, ECG, routine laboratory tests, and BMI \>/= 30 kg/m2 and \</=30 40 kg/m\^2.
- Males and females agree to use described birth control methods.
- Non-smoker.
- Willing and able to be confined to the clinical research facility.
- Willing and able to comply with the protocol and able to communicate with investigators.
- Able to comprehend and willing to provide written informed consent.
Exclusion
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, neurologic, or allergic disease (including drug allergies; patients with untreated, asymptomatic, seasonal allergies may be enrolled), surgical conditions, cancer or any other condition that might in the opinion of the investigator impair the ability of the subject to complete the study or significantly interfere with the absorption, distribution, metabolism, or excretion of the study drugs.
- Evidence or history of clinically significant psychiatric disease including major depression, mania, or hypomania, and history of suicide attempts or suicidal ideation. Subjects with a Beck Depression Inventory-II (BDI-II) score \>13 at screening are excluded.
- Clinically relevant abnormal findings at the screening examination (including laboratory tests and ECG).
- Screening ECG which demonstrates at least one of the following: heart rate \> 100 bpm, QRS \> 120 msec, QTc \> 450 msec, PR \> 220 msec or any rhythm other than sinus rhythm, sinus bradycardia, or sinus arrhythmia.
- Change in weight \> 5 kilograms within 3 months of screening.
- History of alcohol consumption exceeding 14 drinks/week (1 drink equaling 5 ounces of wine, 12 ounces of beer, or 1.5 ounces of hard liquor) within the 6 months before study entry.
- Sitting systolic blood pressure ≤90 millimeters of mercury (mmHg) or ≥140 mmHg, diastolic blood pressure \</= 50 mmHg or \>/= 90 mmHg and judged to be clinically significant by the investigator.
- Positive result on drug screen, hepatitis B surface antigen (HBsAg), hepatitis C (HCV), or human immunodeficiency (HIV) tests.
- Use of prescription or non-prescription drugs, vitamins, or dietary supplements within 14 days prior to the first dose of study medication. Subjects on oral contraceptives and subjects who have used acetaminophen at doses of \< 2 grams/day are eligible for study entry. Any exception to this must be felt not to impact the integrity of the data and must be jointly agreed upon by the investigator and medical monitor.
- Treatment with any investigational drug, use of any known CYP450 enzyme- inducing/inhibiting agents (e.g., barbiturates, phenothiazines, cimetidine, St. John's Wort) or herbal supplements within 30 days prior to the first dose of study medication.
- Treatment with any psychotropic medication within 90 days of screening.
- History of drug abuse or dependence within 180 days of screening.
- Febrile illness within 5 days prior to the first dose of study medication.
- Inadequate venous access.
- Known allergy to sertraline or telenzepine.
- History of an active eating disorder such as anorexia nervosa, bulimia or binge eating disorder.
- Elevated ALT (\> 2X ULN) or total bilirubin (\> 1.6 mg/dL)
- Have diabetes mellitus (fasting plasma glucose \> 126 mg/dL)
- Have been on weight loss medications in the past 6 months
Key Trial Info
Start Date :
May 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01155531
Start Date
May 1 2010
End Date
August 1 2010
Last Update
June 17 2019
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