Phase 1 Completed N=24 Randomized Double-blind Basic Science

A Two-part Single and Multiple Dose Study to Assess the Safety , Pharmacokinetics and Effects of AZD3293 in Healthy Japanese Young and Elderly Volunteers

Healthy Japanese Young and Elderly Male and Non-fertile Female Volunteers

Source: ClinicalTrials.gov NCT02005211 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2015

Primary outcomePrimary: Safety - Adverse Events — 1; 1; 0; 2 Participants

Summary

This study consists of two parts, ie, single dose part with young healthy subjects (Part 1) and single and multiple dose part with elderly healthy subjects (Part 2), to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of AZD3293 following single and multiple ascending dose administration to healthy subjects.

Outcome Measures

Outcome	Result	p-value
PRIMARY Safety - Adverse Events	1; 1; 0; 2; 2; 1	—
SECONDARY PK Cmax - Overall Study	82.5; 395; 1480; 86.6; 395; NA	—
SECONDARY PK AUC - Overall Study (SAD & MAD Parts)	839; 2810; 10700; 877; 3070; NA	—
SECONDARY Biomarker	-9.03; -69.6; -75.8; -62.7; -65.9; -70.2	—

Eligibility Criteria

Inclusion Criteria

Healthy Japanese elderly and young males and females (of non-childbearing potential)
Body mass index (BMI) between 17 and 27 kg/m2 and weigh at least 40 kg and no more than 100 kg

Exclusion Criteria

Psychiatric disease/condition, GI, renal, hepatic, cardiovascular, psychiatric, or retinal diseases or disorders
Use of antipsychotic drugs , or chronic use of antidepressant or anxiolytic drugs.
Frequent use (more than 2 days per week during the last 12 weeks) of tobacco or other nicotine products.
Neurological disease, including seizures, recent memory impairment, or clinically significant head injury.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02005211). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.