Safety & Tolerability of a Combination of Antidepressant and Peptic Ulcer Drug in Overweight Healthy Subjects
Status:
Completed
Trial end date:
2010-08-01
Target enrollment:
Participant gender:
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.