A phase I, open-label, randomized, three-way cross-over study to determine the relative bioavailability of an oral capsule formulation, given both in the fasted state and after a high fat meal, compared to an oral suspension of PSN821 in healthy male volunteers.

A phase I, open-label, randomized, three-way cross-over study to determine the relative bioavailability of an oral capsule formulation, given both in the fasted state and after a high fat meal, compared to an oral suspension of PSN821 in healthy male volunteers. - PSN821 3-way cross-over relative bioavailability study.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON34811

Enrollment

Registered

2009-12-29

Start date

2010-01-13

Completion date

Unknown

Last updated

2024-05-06

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

Conditions

Diabetes Type II

Interventions

Study Medication Active substance: PSN821 Activity: GPR119 agonist Indication: Type 2 Diabetes mellitus Strength: 50 mg/g (oral suspension) / 375 mg (oral capsule) Dosage form: oral suspension/oral c

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: * healthy male * between 18 * 55 years of age * BMI is between 18 * 25 kg/m2 * at screening the state of health must satisfy the entry requirements

Exclusion criteria

Exclusion criteria: * suffering from severe illness such as hepatitis B, hepatitis C or HIV * taken part in more than 3 other drug studies in the 10 months prior to the start of this study * donated blood within the 60 days prior to the start of this study (50 mL or more) * donated more than 1.5 liters during the 10 months prior to the start of this study

Design outcomes

Primary

Measure	Time frame
Pharmacokinetics: Concentrations of PSN821 and its metabolite PSN715297 in plasma will be determined; PK parameters of PSN821 and metabolite PSN715297 will be calculated. Safety: Safety will be monitored by AEs, clinical laboratory (haematology, chemistry and urinalysis), vital signs (supine and standing systolic and diastolic blood pressure, pulse rate) and ECG.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)