A phase I, single center, randomized, double blind, placebo controlled, single ascending dose study to investigate the safety, tolerability, and pharmacokinetics of GRC 17536, a new TRPA1 antagonist, in healthy volunteers.

A phase I, single center, randomized, double blind, placebo controlled, single ascending dose study to investigate the safety, tolerability, and pharmacokinetics of GRC 17536, a new TRPA1 antagonist, in healthy volunteers. - Safety, Tolerability, Pharmacokinetics, Food Effect of GRC 17536

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON36129

Enrollment

Registered

2011-03-17

Start date

2011-03-29

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

Astma, COPD, hoesten, chronische pijn Asthma COPD

Interventions

GRC 17536 administered as GRC 17536 potassium granules or capsules single or multiple doses in the fasted or fed state.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 18 - 45 years of age, male, BMI 18.0 - 28.0 kg/m2, no smokers.

Exclusion criteria

Exclusion criteria: Suffering from: hepatitis B, cancer or HIV/AIDS. In case of participation in another drug study within 60 days before the start of this study or being a blood donor within 90 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
Pharmacokinetics: Plasma and urine PK parameters for GRC17536 Safety : AEs, haematology, serum biochemistry, urinalysis, 12-lead ECGs, vital signs (supine and standing systolic and diastolic blood pressure, pulse rate, respiratory rate, oral body temperature), continuous cardiac monitoring (Part 4 and 6a in volunteers *65 yrs), physical examination.	—

Secondary

Measure	Time frame
Not applicable.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)