Study Evaluating Absorption, Distribution, Metabolism and Excretion (ADME) of Single Dose [14C] AZD2423 in Volunteers - Full Text View

Purpose

Phase I study to evaluate the excretion of radioactivity, the metabolic profile, pharmacokinetics, safety and tolerability following a single oral administration of [14C]AZD2423 in healthy male volunteers aged 50 to 65 years (inclusive).The purpose of this study is to investigate how and how quickly AZD 2423 or its break down products are excreted by analysing blood, faeces and urine samples collected during the study.

Condition	Intervention	Phase
Neuroscience	Drug: AZD2423	Phase 1


Study Type:	Observational
Study Design:	Time Perspective: Prospective
Official Title:	An Open Label, Single Dose, Phase I Study to Evaluate the Excretion of Radioactivity, the Metabolic Profile, Pharmacokinetics, Safety and Tolerability Following Single Oral Administration of [14C]AZD2423 to Healthy Male Volunteers

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Percentage of radioactive dose recovered in urine and faeces and total percentage [ Time Frame: During residential period on Day 1 ] [ Designated as safety issue: No ]
Percentage of radioactive dose recovered in urine and faeces and total percentage [ Time Frame: During residential period on Day 2 ] [ Designated as safety issue: No ]
Percentage of radioactive dose recovered in urine and faeces and total percentage [ Time Frame: During residential period on Day 3 ] [ Designated as safety issue: No ]
Percentage of radioactive dose recovered in urine and faeces and total percentage [ Time Frame: During residential period on Day 4 ] [ Designated as safety issue: No ]
Percentage of radioactive dose recovered in urine and faeces and total percentage [ Time Frame: During residential period on Day 5 ] [ Designated as safety issue: No ]
Percentage of radioactive dose recovered in urine and faeces and total percentage [ Time Frame: During residential period on Day 6 ] [ Designated as safety issue: No ]
Percentage of radioactive dose recovered in urine and faeces and total percentage [ Time Frame: During residential period on Day 7 ] [ Designated as safety issue: No ]
Percentage of radioactive dose recovered in urine and faeces and total percentage [ Time Frame: During residential period on Day 8 ] [ Designated as safety issue: No ]
Concentration of total radioactivity in blood and plasma [ Time Frame: During residential period on Day 1 ] [ Designated as safety issue: No ]
Concentration of total radioactivity in blood and plasma [ Time Frame: During residential period on Day 2 ] [ Designated as safety issue: No ]
Concentration of total radioactivity in blood and plasma [ Time Frame: During residential period on Day 3 ] [ Designated as safety issue: No ]
Concentration of total radioactivity in blood and plasma [ Time Frame: During residential period on Day 4 ] [ Designated as safety issue: No ]
Concentration of total radioactivity in blood and plasma [ Time Frame: During residential period on Day 5 ] [ Designated as safety issue: No ]
Concentration of total radioactivity in blood and plasma [ Time Frame: During residential period on Day 6 ] [ Designated as safety issue: No ]
Concentration of total radioactivity in blood and plasma [ Time Frame: During residential period on Day 7 ] [ Designated as safety issue: No ]
Concentration of total radioactivity in blood and plasma [ Time Frame: During residential period on Day 8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety and tolerability of AZD2423 following administration of a single oral dose of [C14] AZD2423 solution by assessing adverse events [ Time Frame: Range of Day -1 until follow up visit (Visit 3) ] [ Designated as safety issue: Yes ]
Safety and tolerability of AZD2423 following administration of a single oral dose of [C14] AZD2423 solution by assessing concomitant medications [ Time Frame: Range of Day -1 until follow up visit (Visit 3) ] [ Designated as safety issue: Yes ]
Safety and tolerability of AZD2423 following administration of a single oral dose of [C14] AZD2423 solution by assessing clinical chemistry [ Time Frame: Range of Day -1 until follow up visit (Visit 3) ] [ Designated as safety issue: Yes ]
Safety and tolerability of AZD2423 following administration of a single oral dose of [C14] AZD2423 solution by assessing haematology [ Time Frame: Range of Day -1 until follow up visit (Visit 3) ] [ Designated as safety issue: Yes ]
Safety and tolerability of AZD2423 following administration of a single oral dose of [C14] AZD2423 solution by assessing urinalysis [ Time Frame: Range of Day -1 until follow up visit (Visit 3) ] [ Designated as safety issue: Yes ]
Safety and tolerability of AZD2423 following administration of a single oral dose of [C14] AZD2423 solution by assessing vital signs [ Time Frame: Range of Day -1 until follow up visit (Visit 3) ] [ Designated as safety issue: Yes ]
Safety and tolerability of AZD2423 following administration of a single oral dose of [C14] AZD2423 solution by assessing body weight [ Time Frame: Range of Day -1 until follow up visit (Visit 3) ] [ Designated as safety issue: Yes ]
Safety and tolerability of AZD2423 following administration of a single oral dose of [C14] AZD2423 solution by assessing electrocardiogram [ Time Frame: Range of Day -1 until follow up visit (Visit 3) ] [ Designated as safety issue: Yes ]
Safety and tolerability of AZD2423 following administration of a single oral dose of [C14] AZD2423 solution by physical examination [ Time Frame: Range of Day -1 until follow up visit (Visit 3) ] [ Designated as safety issue: Yes ]

Biospecimen Retention: Samples With DNA

Pharmacogenetic samples


Estimated Enrollment:	6
Study Start Date:	November 2010
Study Completion Date:	December 2010
Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
1 Single cohort of 6 subjects	Drug: AZD2423 AZD2423

Eligibility


Ages Eligible for Study:	50 Years to 65 Years (Adult)
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

primary care clinic/community sample

Criteria

Inclusion Criteria:

Have a body mass index (BMI) of ≥18 and ≤30 kg/m2 and weight of ≥50 kg and ≤100 kg
Regular daily bowel movements (ie, production of at least 1 stool per day)
Provision of signed and dated, written informed consent prior to any study specific procedures

Exclusion Criteria:

Healthy volunteers exposed to radiation levels above background (eg, through X ray examination) of >5 mSv in the last year, >10 mSv over the last 5 years or a cumulative total of >1 mSv per year of life
Participation in any prior radiolabelled study within 12 months of the screening visit (Visit 1)
History of alcohol abuse or excessive intake of alcohol defined as regular intake of more than 15 units of alcohol a week. (unit = 1 glass of wine (125 mL) = 1 measure of spirits = ½ pint of beer)

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01223014

Locations


United Kingdom
Research Site
London, United Kingdom

Sponsors and Collaborators

AstraZeneca

Investigators


Study Director:	Biljana Lilja	AstraZeneca
Principal Investigator:	Marianne Kasti	Quintiles, Inc.

More Information


Responsible Party:	Marketing Company Medical Director, AstraZeneca
ClinicalTrials.gov Identifier:	NCT01223014 History of Changes
Other Study ID Numbers:	D2600C00008
Study First Received:	October 15, 2010
Last Updated:	February 6, 2011
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by AstraZeneca:


Radioactive ADME Neuropathic pain

ClinicalTrials.gov processed this record on September 30, 2016

Study Evaluating Absorption, Distribution, Metabolism and Excretion (ADME) of Single Dose [14C] AZD2423 in Volunteers (ADME)