A Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD0914

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01929629
First received: August 23, 2013
Last updated: April 14, 2014
Last verified: April 2014
  Purpose

The purpose of this study is to assess the safety and tolerability of orally administered AZD0914 in healthy adult subjects.


Condition Intervention Phase
Gonococcal (GC) Infection
Drug: Part A
Drug: Part B
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: A Phase I, Randomized, Placebo-controlled, Single-center Study to Assess the Safety, Tolerability, and Pharmacokinetics of AZD0914 After a Single Oral Administration and to Assess the Effect of Food in Healthy Adult Volunteers

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Description of the safety profile in terms of adverse events; blood pressure, heart rate and body temperature; electrocardiograms; telemetry; clinical chemistry ; haematology and physical examination [ Time Frame: From admission on day -1 until follow up. ( Max 16 days) ] [ Designated as safety issue: Yes ]
    Applies to Part A and B


Secondary Outcome Measures:
  • Description of pharmacokinetics(PK) for AZD0914 study part A and B in terms of maximum observed plasma concentration (Cmax) [ Time Frame: Samples taken at predose, and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose ] [ Designated as safety issue: No ]
  • Description of pharmacokinetics(PK) for AZD0914 study part A and B in terms of time to reach maximum observed plasma concentration (tmax) [ Time Frame: Samples taken at predose, and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose ] [ Designated as safety issue: No ]
  • Description of pharmacokinetics(PK) for AZD0914(Part A and B) in terms of AUC from time zero to time of last quantifiable AZD0914 concentration [AUC(0-last)] [ Time Frame: Samples taken at predose, and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose ] [ Designated as safety issue: No ]
  • Description of pharmacokinetics(PK) for AZD0914(Part A and B) in terms of AUC from time zero to 24 hours after dosing [AUC(0-24)] [ Time Frame: Samples taken at predose, and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose ] [ Designated as safety issue: No ]
  • Description of pharmacokinetics(PK) for AZD0914(Part A and B) in terms of terminal half-life (t1/2λz) and apparent plasma clearance (CL/F) [ Time Frame: Samples taken at predose, and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose ] [ Designated as safety issue: No ]
  • Description of pharmacokinetics(PK) for AZD0914(Part A and B) in terms of apparent terminal phase volume of distribution (Vz/F), and at steady state (Vss/F),mean residence time [ Time Frame: Samples taken at predose, and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose ] [ Designated as safety issue: No ]
  • Description of pharmacokinetics(PK) for AZD0914 (Part A and B) in terms of cumulative amount of investigation product (IP) excreted unchanged into urine from zero to time t [Ae(0-t)], [ Time Frame: Samples taken from collections between -12 to 0 hours predose, and 0 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 48, and 48 to 72 hours after the 1st dose ] [ Designated as safety issue: No ]
  • Description of pharmacokinetics(PK) for AZD0914 (Part A and B) in terms of fraction of dose excreted unchanged into urine (fe), and renal clearance (CLr) [ Time Frame: Samples taken from collections between -12 to 0 hours predose, and 0 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 48, and 48 to 72 hours after the 1st dose ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: September 2013
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo fasting
Single or multiple dosing placebo
Drug: Part A
Single ascending doses
Experimental: Active fed condition
AZD0914 given as single dose
Drug: Part B
Single doses food effect. Subjects to receive 2 single doses, one in fed and one in fasted.

Detailed Description:

A Phase I, Randomized, Placebo-controlled, Single-center Study to Assess the Safety, Tolerability, and Pharmacokinetics of AZD0914 After a Single Oral Administration and to Assess the Effect of Food in Healthy Adult Volunteers

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male and female (of non-childbearing potential)subjects aged 18 to55 years (inclusive).
  • Have a body mass index (BMI) between 18.00 and 30.50 kg/m2 and weigh at least 50 kg and no more than 100 kg
  • Male subjects should be willing to use barrier contraception, ie, condoms, from the day of dose administration until at least 3 months after dose administration of the IP

Exclusion Criteria:

  • History of any important clinically significant disease or disorder which, in the opinion of the PI, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study
  • History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs
  • Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks from the first administration of IP as judged by the PI
  • History of gastrointestinal ulcer disease, inflammatory bowel disease, indigestion symptoms >3 times a week, or blood in stool in previous 6 months not related to anal trauma
  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: NCT01929629

Locations
United States, Kansas
Research Site
Overland Park, Kansas, United States
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: David Mathews, MD Quintiles Phase I unit, Kansas
Study Director: Humphrey Gardener, MD AstraZeneca
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01929629     History of Changes
Other Study ID Numbers: D4930C00001
Study First Received: August 23, 2013
Last Updated: April 14, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
Phase 1
Healthy Volunteers
First Time in Man
Pharmacokinetics

Additional relevant MeSH terms:
Gonorrhea
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Sexually Transmitted Diseases, Bacterial
Sexually Transmitted Diseases
Infection
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on August 01, 2014