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

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 - LND101001 single and multiple ascending dose study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON37192

Enrollment

Registered

2012-10-19

Start date

2012-11-01

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

Alzheimer's disease

Interventions

single ascending doses: single administration of a capsule, doses 7.5 - 400 mg (food-effect: 2 drug administrations) multiple ascending doses: one capsule daily during 14 days

dose levels to be determined based on findings in the single ascending dose part of the study.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame
similar primary parameters; data following administration of LND101001 under fasted and fed conditions will be compared and differences between males and females	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)