A RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE I STUDY TO DETERMINE THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND PHARMACODYNAMICS OF SINGLE ASCENDING ORAL DOSES OF P1201-07 IN HEALTHY OVERWEIGHT OR OBESE SUBJECTS

A RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE I STUDY TO DETERMINE THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND PHARMACODYNAMICS OF SINGLE ASCENDING ORAL DOSES OF P1201-07 IN HEALTHY OVERWEIGHT OR OBESE SUBJECTS - P1201-07 SAD study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON32187

Enrollment

Registered

2008-01-18

Start date

2008-02-22

Completion date

Unknown

Last updated

2024-05-13

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

Conditions

Obesity overweight

Interventions

Single doses of P1201-07

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 18-55 year of age for males 18-65 year of age for females

Exclusion criteria

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 outcomes

Primary

Measure	Time frame
AEs, vital signs, ECG-parameters, laboratory parameters, physical parameters	—

Secondary

Measure	Time frame
Plasma P1201-07 concentrations, pharmacokinetic parameters: Cmax, tmax, AUC0-t, AUC0-inf, %AUC, kel, t*, CL, Vz	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)