Primary objective: to assess the safety and tolerability and pharmacokinetics of LND101001 administered as single and multiple doses; Secondary: to assess the effect of food and gender on pharmacokinetics.
ID
Source
Brief title
Condition
- Structural brain disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
similar primary parameters; data following administration of LND101001 under
fasted and fed conditions will be compared and differences between males and
females
Background summary
LND101001 is a new investigational compound (positive allosteric modulator of
the alpha 7 nicotinic acetylcholine receptor) that may be used in the
treatment of Alzheimer's disease. This is a first in human study.
Study objective
Primary objective: to assess the safety and tolerability and pharmacokinetics
of LND101001 administered as single and multiple doses; Secondary: to assess
the effect of food and gender on pharmacokinetics.
Study design
Single ascending doses: 5 groups of 8 volunteers, one group of 10 volunteers (6
LND101001; 2 placebo; 8 : 2 in the group that consists of 10 volunteers); group
2 (FE) will participate in 2 periods and receive the same dose in each period,
under fasted conditions in one period, under fed conditions in the other period
(food-effect part) (6 LND101001; 2 placebo)
Multiple ascending doses: 3 group of 8 volunteers (6 LND101001; 2 placebo)
Intervention
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.
Study burden and risks
- possible side-effects as decribed under E9
- venipunctures and blood draws via cannula
- pre-screening and follow-up visit
- admission in clinic
- several ambulant visits
- study activities: a.o: physical examinations (SAD 3x, MAD 4x), telemetric
monitoring, ECG's, vital signs
CST Road, Kalina 159
Santacruz, Mumbai 400098
IN
CST Road, Kalina 159
Santacruz, Mumbai 400098
IN
Listed location countries
Age
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2012-004141-32-NL |
| CCMO | NL42152.056.12 |