A Phase 1, 2-part, Open Label Pharmacokinetic and Safety Study to Evaluate Dose Proportionality and Accumulation of Firdapse® (3,4-Diaminopyridine Phosphate) after Single and Multiple Oral Doses in Healthy Volunteers

A Phase 1, 2-part, Open Label Pharmacokinetic and Safety Study to Evaluate Dose Proportionality and Accumulation of Firdapse® (3,4-Diaminopyridine Phosphate) after Single and Multiple Oral Doses in Healthy Volunteers - Firdapse® PK study in healthy volunteers

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON36156

Enrollment

Registered

2011-02-23

Start date

2011-03-14

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

LEMS muscle weakness

Interventions

Active substance: amifampridine

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Healthy male or female Age between 18 and 55 years, inclusive. BMI between 18 and 30 kg/m2, inclusive. Non smoking

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 any blood or significant loss of blood within 60 days of the start of drug dosing.

Design outcomes

Primary

Measure	Time frame
- pharmacokinetics - safety	—

Secondary

Measure	Time frame
n.a.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)