GBA-PD Patient Imaging study of LTI-291 versus placebo.

A RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND, PARALLEL IMAGING STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND PHARMACODYNAMICS BY FMRI AND FDG-PET ASSESSMENTS OF MULTIPLE ORAL DOSES OF LTI-291 IN PATIENTS WITH PARKINSON’S DISEASE WITH A GBA1 MUTATION

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON24854

Enrollment

Registered

2018-05-30

Start date

2018-06-05

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Parkinson's disease

Interventions

Multiple doses of LTI-291 10 or 60 mg once daily for 28 days.

Eligibility

Inclusion criteria

Inclusion criteria: Mannelijke of vrouwelijke vrijwilliger; ziekte van Parkinson met een GBA1 mutatie; minimaal 18 jaar; BMI 18.0 - 35.0 (kilogram/meter2); gewicht minstens 45 kilogram.

Exclusion criteria

Exclusion criteria: Lijdend aan hepatitis B, diabetes, hepatitis C, kanker of HIV/AIDS. Indien gedurende de 90 dagen voorafgaand aan de start van dit onderzoek aan een ander geneesmiddelenonderzoek is deelgenomen. Indien gedurende de 60 dagen voor start van dit onderzoek bloed is gegeven.

Design outcomes

Primary

Measure	Time frame
To evaluate the safety and tolerability of two oral dose levels of LTI-291 (10 and 60 mg) following 28 days of treatment in patients with GBA-PD.	—

Secondary

Measure	Time frame
To characterize the plasma PK of LTO-291 (10 and 60 mg) in patients with GBA-PD.	—

Contacts

Public ContactDana Hilt

dana.hilt@lysosomaltx.com+1-617 714 9889

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)