A PHASE I STUDY, TO DETERMINE THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND FOOD EFFECT OF SINGLE AND MULTIPLE DOSES OF ORALLY ADMINISTERED HM71224 IN HEALTHY, ADULT MALE VOLUNTEERS

A PHASE I STUDY, TO DETERMINE THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND FOOD EFFECT OF SINGLE AND MULTIPLE DOSES OF ORALLY ADMINISTERED HM71224 IN HEALTHY, ADULT MALE VOLUNTEERS - HM71224 SAD/FE/MAD study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON40064

Enrollment

Registered

2012-11-01

Start date

2013-01-29

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

Reumatoide Arhtritis/Chronisch Inflammatoire aandoening Rheuma Rheumatoid Arthritis

Interventions

Part A SAD: Group Period Treatment No. of tablets How often 1 1 10 mg HM71224 or placebo 2 x 5 mg Single dose 2 40 mg HM71224 or placebo 2 x 20 mg Single dose 3 160 mg HM71224 or placebo 8 x 20 mg

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Gender: male Age: 18 * 65 years, inclusive BMI: 18.5 * 30.0 kg/m2, inclusive Non-smokers for at least 60 days: (Part A and B) or 2 years (Part C).

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 the study. In case of donating blood or significant loss of blood within 60 days of the start of drug dosing.

Design outcomes

Primary

Measure	Time frame
Safety; AEs, vital signs, 12-lead ECG, clinical laboratory, physical examination; and Part C only: DLCO, SpO2, Lung auscultation, and Sp-D.	—

Secondary

Measure	Time frame
PK: plasma and urine HM71224 concentrations: plasma and urine PK parameters. Exploratory PD : BTK occupancy, CD63+ (Part C only)	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)