A PHASE 1, SINGLE ASCENDING DOSE, MULTIPLE ASCENDING DOSE AND SINGLE DOSE FOOD EFFECT STUDY TO INVESTIGATE THE SAFETY, TOLERABILITY AND PHARMACOKINETICS OF LND101001 IN HEALTHY MALE AND FEMALE SUBJECTS

Completed

Conditions: dementia
10042258
Alzheimer's disease

Registration Number: NL-OMON37192

Lead Sponsor: upin Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 74

Inclusion Criteria

- SAD: healthy male and female subjects, MAD: healthy male subjects
- 18-65 yrs, inclusive
- BMI: 18.0-30.0 kg/m2, inclusive
- non-smoking

Exclusion Criteria

Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of participation in another drug study within 90 days before the start of this study or being a blood donor within 60 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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Criteria for evaluation<br /><br>Pharmacokinetics: concentration of LND101001 in plasma after single and<br /><br>multiple ascending doses, PK parameters<br /><br>Safety: AEs, vital signs, 12-lead ECG, telemetry, clinical laboratory, physical<br /><br>examination<br /><br><br /><br>Statistical Methods:<br /><br>PK parameters : analysis of variance on Cmax and AUC, other parameters<br /><br>descriptive statistics<br /><br>Safety parameters : descriptive statistics</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>similar primary parameters; data following administration of LND101001 under<br /><br>fasted and fed conditions will be compared and differences between males and<br /><br>females</p><br>