A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, SAFETY, TOLERABILITY AND PHARMACOKINETIC STUDY OF SINGLE INTRAVENOUS DOSES OF GNX-5086 IN HEALTHY SUBJECTS

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, SAFETY, TOLERABILITY AND PHARMACOKINETIC STUDY OF SINGLE INTRAVENOUS DOSES OF GNX-5086 IN HEALTHY SUBJECTS - GNX-5086 SAD study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON40482

Enrollment

105

Registered

2013-07-16

Start date

2013-07-29

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

Acute myocardial infarction heart attack

Interventions

Single dose of GNX-5086 via intravenous infusion with maximum of 1200 mg

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: healthy male 25 - 45 years inclusive BMI 18.0 - 30.0 kg/m2 inclusive non-smoker

Exclusion criteria

Exclusion criteria: Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. Participation in another drug study within 60 days prior to randomization. Any donation of blood(products) or significant blood loss within 60 days prior to drug administration

Design outcomes

Primary

Measure	Time frame
Safety Tolerability	—

Secondary

Measure	Time frame
PK	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)