WithdrawnNCT01275781Updated Jan 29, 2013

Study in Healthy Males to Assess Distribution, Metabolism, and Excretion of Radio-labelled AZD9742 Administered as a 2-hour Infusion

A Phase 1 interventional study of [14C]-AZD9742 in Healthy, sponsored by AstraZeneca. Withdrawn at 1 site in United States. Open to male participants aged 55 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-01-29.

Sponsored by AstraZeneca · Phase 1, Interventional, and Basic science

Why this study was withdrawn

Withdrawn due to the local Radiation Safety Committee refusing to approve it.

Phase: Phase 1
Study type: Interventional
Enrollment: 0
Allocation: Not applicable
Ages: 55 Years and older
Sex: Male

Study summary

The purpose of this study is to assess distribution, metabolism, and excretion of radio-labelled AZD9742 administered as a 2-hour infusion to healthy male volunteers.

Conditions studied

Healthy

Keywords

Phase 1
healthy male volunteers
radioactivity
excretion
metabolism
AZD9742
amount of radioactive AZD9742 in urine, feces, and vomitus (if appropriate)

In context

Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 55 Years and older
Sexes eligible: Male
Accepts healthy volunteers: Yes

Inclusion criteria

Healthy male volunteers age 55 years or older on Day 1, body weight >50 kg, body mass index (BMI) between 18 kg/m2 and 30 kg/m2
Regular bowel movements, at least once per day (self reported)
Volunteers must be willing to have intravenous (IV) and blood sampling from either arm.
Volunteers should ensure that their partners of child-bearing potential use a reliable method of contraception, as well as using a barrier method themselves.

Exclusion criteria

Exclusion Criteria:

History of any clinically significant disease or abnormalities, including history or presence of gastrointestinal, hepatic, renal disease or any other condition known to interfere with metabolism, or excretion of drugs
Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of investigational product
Current smokers or those who have smoked or used nicotine products within the previous 30 days
History of alcohol abuse or excessive intake of alcohol
Participation in more than 1 other radiolabeled investigational study drug trial within 1 year prior to check-in. The previous radiolabeled study drug had to be received more than 6 months prior to check-in and the total exposure from this study and the previous study must be within the CFR recommended levels considered safe (per 21 CRF 362.1, less than 5,000 mrem whole body annual exposure).

Study design

Phase: Phase 1
Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 0 participants (actual)

Study arms

Experimental
A
\[14C\]-AZD9742 1000 mg intravenous over 2 hours
Drug: [14C]-AZD9742

Interventions

Drug[14C]-AZD9742
1000 mg intravenous over 2 hours

What researchers measure

Primary outcomes

To characterize the distribution and elimination of AZD9742 and total 14C radioactivity in healthy volunteers following a single 1000 mg intravenous (IV) dose of [14C]-AZD9742 administered as a 2-hour infusion.
12 hours pre dose to 168 hours post dose of the treatment period if the patient meets discharge criteria. If the patient does not meet discharge criteria after 168 hours post dose, additional 24 hour collections up to 7 additional days or until discharge criteria are met, whichever occurs first.
Time frame: Range of 12 hours pre dose to 168 hours post dose
To evaluate the excretion of 14C (mass balance) in urine and feces after a single 1000 mg intravenous (IV) dose of [14C]-AZD9742 administered as a 2-hour infusion.
12 hours pre dose to 168 hours post dose of the treatment period if the patient meets discharge criteria. If the patient does not meet discharge criteria after 168 hours post dose, additional 24 hour collections up to 7 additional days or until discharge criteria are met, whichever occurs first.
Time frame: Range of 12 hours pre dose to 168 hours post dose

Secondary outcomes

Safety of AZD9742 after a single intravenous 14C administration of AZD9742, by assessing a panel of measures: Adverse Events, vital sign evaluations, physical examination, electrocardiograms (ECG) and clinical laboratory parameters.
To explore and establish the metabolite profiles in plasma and excreta; where possible the identity of metabolites will be determined.
Time frame: Immediately prior to the end of the infusion, 4 hours after the end of the infusion and 24 hours after the start of the infusion.

Study locations

1 site

Research Site
Overland Park, Kansas, United States

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jan 29, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01275781
Lead sponsor: AstraZeneca
First posted: Jan 12, 2011
Start date: Jan 2011
Primary completion: Feb 2011 (estimated)
Completion: Feb 2011 (estimated)
Last update: Jan 29, 2013

Study contacts

David Melnick, MD

study director · AstraZeneca

Ralph Schutz, MD

principal investigator · Quintiles, Inc.

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jan 2013. You cannot join it, but the record below documents what was studied.

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