A phase 1 study to investigate the absorption, metabolism and excretion of [14C] AT1001 (migalastat hydrochloride) following a single oral administration in healthy volunteers.

A phase 1 study to investigate the absorption, metabolism and excretion of [14C] AT1001 (migalastat hydrochloride) following a single oral administration in healthy volunteers. - [14C]-AT1001 tracer label study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON35820

Enrollment

Registered

2011-05-30

Start date

2011-08-08

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

Metabolic disease

Interventions

Study Medication Active substance: AT1001 and [14C]-AT1001 Activity : pharmacological chaperone for *-Gal A Indication : Fabry disease Dosage form: oral solution Treatment A single oral dose of 150

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Healthy male subjects, 30 - 55 years, BMI of *18.0 to *30.0, no 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 this study or being a blood donor within 90 days from the start of the study. In case of donating more than 1.5 liters of blood in the 10 months prior the start of this study.

Design outcomes

Primary

Measure	Time frame
Criteria for evaluation Radiokinetics : total radioactivity in plasma, urine and faeces, cumulative excretion (also based on the area under the excretion rate versus time curves in urine and faeces, metabolite elucidation and identification Pharmacokinetics : plasma, urine and faeces AT1001 concentrations, pharmacokinetic parameters Safety : adverse events, vital signs, ECG-parameters, laboratory parameters, physical examination	—

Measure

Time frame

Criteria for evaluation Radiokinetics : total radioactivity in plasma, urine and faeces, cumulative excretion (also based on the area under the excretion rate versus time curves in urine and faeces, metabolite elucidation and identification Pharmacokinetics : plasma, urine and faeces AT1001 concentrations, pharmacokinetic parameters Safety : adverse events, vital signs, ECG-parameters, laboratory parameters, physical examination

—

Secondary

Measure	Time frame
Not applicable.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)