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Cardiovascular effects of apelin infusion in healthy male subjects

Cardiovascular effects of apelin infusion in healthy male subjects - Cardiovascular effects of apelin infusion

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON39109
Enrollment
15
Registered
2012-06-27
Start date
2012-07-25
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

cardiovasculaire ziekten heart- and bloodvessel diseases

Interventions

In the first period the subjects will receive 3 different infusions: - Apelin will be administrated by infusion at 3 dose levels (0.3, 3.0 and 30 nmol/min) for 30 minutes each. - SNP will be adminis

Sponsors

Eli Lilly
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: healthy male subjects 18-55 yrs, inclusive BMI: 18.5-30.0 kg/m2, inclusive non-smoking or less than 10 cigarettes/day

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

MeasureTime frame
Pharmacodynamics: hemodynamic assessments, cardiac index, ATII pressor test, NE pressor test and Glomerular Filtration Rate (GFR) Pharmacokinetics: plasma apelin and iohexol concentrations, pharmacokinetic parameters Safety: adverse events, vital signs, ECG-parameters, laboratory parameters, physical examination

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)