Safety & Tolerability of a Combination of Antidepressant and Peptic Ulcer Drug in Overweight Healthy Subjects
Condition: Obesity
MeSH terms: Overweight
Study type: Interventional
Phase: Phase 1

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 mouth by healthy, overweight, adult men and women.

      In this study, up to 12 people will be assigned to one of 4 groups: A, B, C, and D, and will
      receive 0, 50, 100, or 150 mg of sertraline per day. People in Groups B, C, or D will receive
      an initial dose of 50 mg sertraline. People in Groups C and D will receive an additional 50
      mg of sertraline per week.

      Up to 10 people from each group who were able to tolerate their sertraline dose for at least
      5 days will begin taking 50 mg of sertraline plus doses of telenzepine that will increase
      from 1 mg to 2 mg to 3 mg over a 7-day period (they will receive each combination). On the
      day before they begin taking this combination of drugs, their appetite will be evaluated (on
      a visual scale of 0 to 100) before and after 3 meals.

      The appetites of each person, assessed by the visual scale, will be evaluated on the last day
      of the period (Day 7) before and after 3 meals of each combination treatment, while they are
      staying in the research unit. The amount of food they eat will be determined.

      Based on safety and tolerability assessments of individuals, and of the previous groups who
      received lower doses of the combination of drug, a decision will be made whether to further
      increase the dose of these drugs.

      Since the appetites of each person will be evaluated on the last day of the period (Day 7)
      before and after 3 meals of each combination treatment, people in this study will stay in the
      research unit for approximately 2½ days, starting on Day 6 of their previous treatment, so
      appetite evaluations can be made on Day 7 after a fixed meal in the evening of Day 6. These
      people will continue the stay in the research unit when they begin each telenzepine dose
      increase, so a 24 hour safety observation may be made immediately after the increase.

      After the final doses of telenzepine have been received, people in Groups C and D will
      continue to receive sertraline 50 mg per day for an additional 7 days or until the study
      physician decides when sertraline should be discontinued. People will return to the study
      unit for final visit, 2 weeks after they have received their last sertraline dose.
    


Intervention name(s): Sertraline plus Telenzepine
Intervention type(s): Drug
Intervention description(s): oral sertraline tablets at 0, 50, 100, or 150/day plus oral telenzepine capsules at 0, 1, 2, or 3 mg/day for 7 days in each combination
Intervention MeSH terms: Sertraline; Telenzepine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Obesity; Overweight; Sertraline; Telenzepine; Decrease appetite; Reduce appetite; Lose weight