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

Completed

• Conditions: LEMS; 10029317; muscle weakness

• Registration Number: NL-OMON36156
• Lead Sponsor: BioMarin Pharmaceutical Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 26

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- pharmacokinetics<br /><br>- safety</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>n.a.</p><br>