A randomized, parallel-group clinical pharmacology study to assess the pharmacokinetics and pharmacodynamics of Tysabri® in healthy volunteers

A randomized, parallel-group clinical pharmacology study to assess the pharmacokinetics and pharmacodynamics of Tysabri® in healthy volunteers - Tysabri® PK/PD Study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON46349

Enrollment

Registered

2018-03-05

Start date

2018-03-19

Completion date

Unknown

Last updated

2024-04-15

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

Conditions

Multiple Sclerosis

Interventions

Tysabri will be given as an intravenous infusion (solution of the compound that will be administered directly in a blood vessel) over 60 minutes. The volunteer will receive one of 3 doses of Tysabri

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Healthy males and females. 18-65 years, inclusive, at screening. BMI: 18.5-32.0 kg/m2. Weight: 50.0-110.0 kg.

Exclusion criteria

Exclusion criteria: Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. Presence of JCV antibodies. In case of participation in another drug study within 90 days before the start of this study.

Design outcomes

Primary

Measure	Time frame
Pharmacokinetics and pharmacodynamics	—

Secondary

Measure	Time frame
N.A	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)