To determine the safety and tolerability of P1201-07 administered as single ascending oral doses in overweight or obese but otherwise healthy subjects.
ID
Source
Brief title
Condition
- Appetite and general nutritional disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
AEs, vital signs, ECG-parameters, laboratory parameters, physical parameters
Secondary outcome
Plasma P1201-07 concentrations, pharmacokinetic parameters: Cmax, tmax, AUC0-t,
AUC0-inf, %AUC, kel, t*, CL, Vz
Background summary
It is well known that an increase in the transmission of serotonin (also known
as 5 hydroxytryptamine (5-HT)), in the brain regulates feeding habits by
inducing a reduction in food intake. Earlier appetite suppressants such as
fenfluramine and d-fenfluramine were found to reduce the food intake in both
rats and humans primarily by blocking the 5-HT reuptake in the neuronal synapse
and also causing a 5-HT release from the synapse. Data from human studies
corroborated laboratory findings, indicating that there was a direct effect in
decreasing food intake with enhanced satiety when the neuronal 5-HT receptors
were pharmacologically stimulated.
Hence, 5-HT2C receptor agonist programs are developed to identify and
characterize a highly selective 5-HT2C receptor agonist and to test the
hypothesis that oral treatment with this agent will lead to sustained weight
loss (fat loss) in obese patients, which in turn will result in an improvement
in co-morbid risk factors.
The clinical candidate, P1201-07 is an orally active compound with selective
5-HT2C receptor agonist properties.
Study objective
To determine the safety and tolerability of P1201-07 administered as single
ascending oral doses in overweight or obese but otherwise healthy subjects.
Study design
A single-centre, randomized, double-blind, placebo-controlled study with single
ascending doses in 2 cohorts of 8 overweight or obese but otherwise healthy
male or female subjects. Each cohort may participate in up to 4 periods in an
alternating fashion, with 6 subjects receiving a single oral dose of P1201-07
each period and 2 subjects receiving a single oral dose of placebo each period.
Intervention
Single doses of P1201-07
Study burden and risks
Compound; reduction in food consumption and body weight, red staining of the
mouth, nostrils and eyes, poor grooming and noisy respiration, decreased motor
activity, decrease in body temperature, increase in heart rate and blood
pressure.
Similar drugs that are marketed have demonstrated effects such as nauseau,
vomiting and headache.
Procedures: The insertion of the indwelling canula and the venepuncture may
cause pain, and lead to a bruise. Light bleeding and possibly an infection. The
use of ECG (heart trace) gel/electrodes on the skin may cause allergy or skin
reactions. Some discomfort may be experienced due to the intake of the high fat
meal on day 1 of each period.
Nicholas Piramal Towers, Peninsula Corporate Park, Ganpatrao Kadam Marg
Mumbai 400 013
India
Nicholas Piramal Towers, Peninsula Corporate Park, Ganpatrao Kadam Marg
Mumbai 400 013
India
Listed location countries
Age
Inclusion criteria
18-55 year of age for males
18-65 year of age for females
Exclusion criteria
* Regular treatment with non-topical medications within 90 days prior to drug administration.
* History of alcohol abuse or drug addiction (including soft drugs like cannabis products)
* Use of concomitant medication including sedatives and steroids, except for paracetamol, at least 14 days prior to the first dose
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2007-006704-38-NL |
| CCMO | NL21434.056.08 |