A Phase 1, Randomized, Double-Blind, Placebo Controlled, Single Dose Escalation Trial to Evaluate the Safety, Tolerability and Pharmacokinetics of Migalastat Hydrochloride given Intravenously to Healthy Volunteers with an Open-Label, Randomized, Two-Way Crossover Arm

A Phase 1, Randomized, Double-Blind, Placebo Controlled, Single Dose Escalation Trial to Evaluate the Safety, Tolerability and Pharmacokinetics of Migalastat Hydrochloride given Intravenously to Healthy Volunteers with an Open-Label, Randomized, Two-Way Crossover Arm - Migalastat hydrochloride SAD study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON40853

Enrollment

Registered

2014-03-04

Start date

2014-03-11

Completion date

Unknown

Last updated

2024-04-23

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

Conditions

Fabry disease lysosomal storage disease

Interventions

The study will consist of 1 period during which you will receive migalastat hydrochloride once or placebo once. Migalastat hydrochloride and placebo will be given as a 2 hour intravenous infusion.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - healthy male and female subjects - 18-45 yrs, inclusive - BMI: 18.5-29.9 kg/m2, inclusive - non-smoking

Exclusion criteria

Exclusion criteria: Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of participation in another drug study within 60 days prior to dosing day or being a blood donor (>500 mL) within 60 days from the start of the study.

Design outcomes

Primary

Measure	Time frame
1. Plasma pharmacokinetics 2. Safety: adverse events including infusion site reactions, clinically significant changes in safety laboratory tests, vital signs, physical examinations, and ECG	—

Secondary

Measure	Time frame
1. Plasma pharmacokinetics 2. Urinary pharmacokinetics	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)