A PHASE I, SINGLE CENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED, SINGLE DOSE STUDY IN HEALTHY FEMALE AND ELDERLY VOLUNTEERS AND MULTIPLE ASCENDING DOSE STUDY IN HEALTHY MALE AND FEMALE VOLUNTEERS BETWEEN THE AGES OF 18-80 YEARS TO INVESTIGATE THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF GRC 17536

A PHASE I, SINGLE CENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED, SINGLE DOSE STUDY IN HEALTHY FEMALE AND ELDERLY VOLUNTEERS AND MULTIPLE ASCENDING DOSE STUDY IN HEALTHY MALE AND FEMALE VOLUNTEERS BETWEEN THE AGES OF 18-80 YEARS TO INVESTIGATE THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF GRC 17536 - SAD and MAD study of GRC 17536 in healthy volunteers

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON38062

Enrollment

Registered

2011-07-19

Start date

2011-08-25

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 single or multiple doses in the fed state.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Part 1: healthy females, 18 - 45 and 46 - 65 years of age, BMI 18.0 - 30.0 kg/m2, no smokers Part 2: healthy elderly males and females, 65 - 80 years of age, BMI 18.0 - 30.0 kg/m2, no smokers Part 3: healthy young and elderly males, 18 - 45 and 65 - 80 years of age, and healthy young and elderly females, 18 - 45 years of age and 65 - 80 years of age, BMI 18.0 - 30.0 kg/m2, no smokers Part 4: healthy males, 18 - 45 years of age, BMI 18.0 - 30.0 kg/m2, no smokers;18 - 80 years of age, male and female, BMI 18.0 - 30.0 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 60 days from the start of the study. In case of have taken part in more than 3 other drug studies (for men) or more than 2 other drug studies (for women) in the 10 months prior to the start of this study, or when having donated more than 1.5 liters of blood (for men) or more than 1.0 liters of blood (for women) in the 10 months prior to the start of this study

Design outcomes

Primary

Measure	Time frame
Pharmacokinetics: Plasma and urine PK parameters for GRC17536 (Part 1 - 3), concentration of GRC 17356 in Cerebrospinal Fluid (liquor)(Part 4) 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 2 and 3 in volunteers *65 yrs), physical examination.	—

Measure

Time frame

Pharmacokinetics: Plasma and urine PK parameters for GRC17536 (Part 1 - 3), concentration of GRC 17356 in Cerebrospinal Fluid (liquor)(Part 4) 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 2 and 3 in volunteers *65 yrs), physical examination.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)