A Phase 1, Dose Escalation Study to Evaluate the safety tolerability and pharmacokinetics of single oral doses of ELND007 in healthy elderly subjects.

A Phase 1, Dose Escalation Study to Evaluate the safety tolerability and pharmacokinetics of single oral doses of ELND007 in healthy elderly subjects. - ELND007 SAD in elderly

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON34459

Enrollment

Registered

2010-06-15

Start date

2010-07-02

Completion date

Unknown

Last updated

2024-05-06

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

Conditions

Alzheimer Alzheimer dementia

Interventions

Study medication Active substance : ELND007 Activity : *-secretase inhibitor (GSI) Indication : Alzheimer*s disease Strength : 1 mg/mL and 10 mg/mL Dosage form : capsule with olive oil Treatments Coh

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Healthy elderly volunteers, between 55 and 80 years of age, BMI is

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 past 10 months prior to the start of this study.

Design outcomes

Primary

Measure	Time frame
Pharmacodynamics : plasma Aß concentrations Pharmacokinetics : plasma ELND007 concentrations, pharmacokinetic parameters Safety : adverse events, vital signs, ECG-parameters, laboratory parameters, physical examination, telemetry	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)