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A Single Dose Study of the Pharmacodynamics, Tolerability, and Pharmacokinetics of GAL-054

A Single Dose Study of the Pharmacodynamics, Tolerability, and Pharmacokinetics of GAL-054 - Single Dose PD and Tolerability of GAL-054

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON37672
Enrollment
36
Registered
2011-10-07
Start date
2011-10-17
Completion date
Unknown
Last updated
2024-05-06

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

Conditions

Breath disorders

Interventions

24-36 healthy male and female volunteers will participate in this 2-part trial. Part 1 is a 7-period study. During the first 6 periods approximately 12 subjects will receive a single intravenous inf

Sponsors

Galleon Pharmaceuticals, Inc.
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Healthy volunteer 18-45 years

Exclusion criteria

Exclusion criteria: Clinical significant abnormalities

Design outcomes

Primary

MeasureTime frame
The pharmacodynamic effects of GAL-054 in comparison to doxapram in healthy subjects

Secondary

MeasureTime frame
Tolerability and pharmacokinetics

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)