A phase I study to investigate the pharmacokinetics, safety and tolerability of four different dosing regimens of GRC 17536 in healthy male volunteers using tablet formulation.

A phase I study to investigate the pharmacokinetics, safety and tolerability of four different dosing regimens of GRC 17536 in healthy male volunteers using tablet formulation. - GRC 17536 multiple dose study in healthy volunteers.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON42613

Enrollment

Registered

2015-03-12

Start date

2015-03-26

Completion date

Unknown

Last updated

2024-04-23

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

Conditions

Pijn en luchtwegaandoeningen Pain and respiratory conditions

Interventions

n.a.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: healthy male subjects 18 - 45 years of age, inclusive BMI 18.0 - 28.0 kilograms/meter2, inclusive weight at least 50 kilograms

Exclusion criteria

Exclusion criteria: Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of participation in another drug study within 90 days before the start of this study or being a blood donor within 60 days from the start of the study. In case of donating more than 1.5 liters of blood in the 10 months prior the start of this study.

Design outcomes

Primary

Measure	Time frame
To assess the pharmacokinetics of GRC 17536 following multiple oral administration of tablet formulations at four different dose levels: (a) two tablets of 90 mg GRC 17536 twice daily (i.e., 360 mg daily dose), (b) three tablets of 90 mg GRC 17536 twice daily (i.e., 540 mg daily dose), (c) four tablets of 90 mg GRC 17536 twice daily (i.e., 720 mg daily dose), and (d) three tablets of 45 mg twice daily (i.e., 270 mg daily dose) administered in normal healthy adult male subjects.	—

Measure

Time frame

To assess the pharmacokinetics of GRC 17536 following multiple oral administration of tablet formulations at four different dose levels: (a) two tablets of 90 mg GRC 17536 twice daily (i.e., 360 mg daily dose), (b) three tablets of 90 mg GRC 17536 twice daily (i.e., 540 mg daily dose), (c) four tablets of 90 mg GRC 17536 twice daily (i.e., 720 mg daily dose), and (d) three tablets of 45 mg twice daily (i.e., 270 mg daily dose) administered in normal healthy adult male subjects.

—

Secondary

Measure	Time frame
To evaluate the safety and tolerability of GRC 17536 in normal healthy adult male subjects following multiple oral administration of the tablet formulations.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)