Study of Uptake, Break Down and Elimination of an Investigational Drug in Healthy Volunteers

An Open, Two Period, Single Dose, Phase I Study of the Excretion of Radioactivity, Metabolic Profiles and Pharmacokinetics Following Oral Administration of [14C]-AZD3480 and the Pharmacokinetics of AZD3480 Following Intravenous Administration to Healthy Male Volunteers With Different CYP2D6 Genotype

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00777361

Acronym

Enrollment

Registered

2008-10-22

Start date

2008-10-31

Completion date

2009-10-31

Last updated

2010-11-18

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

Conditions

Alzheimer's Disease

Keywords

Mass balance, AZD3480, Pharmacokinetics, Healthy volunteers

Brief summary

This study is being performed in order to learn more about a new drug (possible as treatment for people with Alzheimer's Disease and other conditions with cognitive dysfunction (memory and attention problems)) and how it is handled by the body by giving the drug to healthy volunteers with different genotypes.

Interventions

DRUGAZD3480

Iv single dose, 4-hour infusion of 25 mg

Study design

Allocation

NON_RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

35 Years to 65 Years

Healthy volunteers

Yes

Inclusion criteria

* Physically healthy volunteers * Participation in a previous study for genotyping for identification to be extensive, intermediate or poor metaboliser (CYP2D6 enzyme)

Exclusion criteria

* History of clinically significant diseases or illness. * Ues of any prescribed or non-prescribed medications from 2 weeks prior to first treatment day except for paracetamol and OTC adrenergic nasal spray.

Design outcomes

Primary

Measure	Time frame
Recovery (% dose) of radioactivity retrieved in urine and faeces Total radioactivity in blood and plasma, AUC, Cmax , tmax, t1/2 and blood/plasma ratio.	Urine and faeces collection for at least 168 hours (up to 2 weeks)9 (blood) and 17 (plasma) samples during 48 and 72 hours.
Plasma and urine concentration (AUC, Cmax, tmax, t1/2, F, CL, CLR, fe, Ae, and Vss)	19 and 18 blood samples during 72 and 96 hours after iv (Visit 2) and po dosing (Visit 3) respectively. Urine collection for 72 hours and 168 hours (up to 2 weeks).

Secondary

Measure	Time frame
identity of major metabolites in plasma and excreta	4 blood samples during 8 hours.Urine and faeces collection for at least 168 hours (up to 2 weeks).
Adverse Events, vital signs (supine blood pressure and pulse rate), ECG, hematology, clinical chemistry and urinalysis.	From enrollment to follow-up

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026