TerminatedPhase 1

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

Lead sponsor

AstraZeneca

Asset

AZD3480

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criterion

•Healthy volunteers

Primary endpoints

•Recovery (% dose) of radioactivity retrieved in urine•Plasma and urine concentration

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDD3690C00017

SecondaryEudraCT No.: 2007-005903-16

NCT IDNCT00777361

Timeline

Milestones

Study start2008-10 (month precision)

Study first posted2008-10-22estimated

Primary completion2009-10actual (month precision)

Study completion2009-10actual (month precision)

Last update posted2010-11-18estimated

Assets

Drug assets

AZD3480

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age35 Years

Maximum age65 Years

SexMale

Healthy volunteersAccepted

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.

Endpoints (4)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK

Other (unclassified)

Safety / tolerability / PK

3 endpoints

Primary/protocol endpoint

Recovery (% dose) of radioactivity retrieved in urine and faeces Total radioactivity in blood and plasma, AUC, Cmax , tmax, t1/2 and blood/plasma ratio.

Time frame:Urine and faeces collection for at least 168 hours (up to 2 weeks)9 (blood) and 17 (plasma) samples during 48 and 72 hours.

concentration, descriptive

Primary/protocol endpoint

Plasma and urine concentration (AUC, Cmax, tmax, t1/2, F, CL, CLR, fe, Ae, and Vss)

Time frame: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).

concentration, descriptive

Secondary/protocol endpoint

Adverse Events, vital signs (supine blood pressure and pulse rate), ECG, hematology, clinical chemistry and urinalysis.

Time frame:From enrollment to follow-up

event count, event

Other (unclassified)

1 endpoint

Secondary/protocol endpoint/low confidence

identity of major metabolites in plasma and excreta

Time frame:4 blood samples during 8 hours.Urine and faeces collection for at least 168 hours (up to 2 weeks).

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.