A Bioavailability Study Comparing 3 Different AZD1981 Tablets

NCT01311635 | Completed Phase 1

• 1 other identifier: D9830C00020
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to study the relative bioavailability of AZD1981 when using a new tablet compared to the current tablet.

Conditions

Healthy

Keywords

Phase 1; bioavailability study; AZD1981; tablets; To study the relative bioavailability of single dose AZD1981 via three different tablets; To compare the bioavailability between three different AZD1981 tablets

Outcome Measures

Primary Outcomes (1)

• Assessment of the area under the plasma concentration time-curve from zero to infinity /AUC) and the maximum plasma concentration (Cmax) of AZD1981

  Pharmacokinetic (PK) sampling continuously for 60 h after each single dose, ie day 1-3 for each period.

Secondary Outcomes (2)

• To evaluate basic systemic PK parameters as follows:

  PK sampling continuously for 60 h after each single dose, ie day 1-3 for each period

• To evaluate the safety and tolerability of AZD1981 by assessment of adverse events, laboratory safety parameters, vital signs, ECG, physical examination and weight

  Safety will be monitored continuously and safety assessments will be made on several occasions throughout the whole study

Study Arms (4)

Treatment A

EXPERIMENTAL

Drug: AZD1981, current small-particle tablet

Treatment B

EXPERIMENTAL

Drug: AZD1981, new small-particle tablet

Treatment C

EXPERIMENTAL

Drug: AZD1981, new small-particle tablet

Treatment D

EXPERIMENTAL

Drug: AZD1981, new large-particle table

Interventions

AZD1981, current small-particle tablet DRUG

3x100 mg per oral, single dose in fasted state

Treatment A

AZD1981, new small-particle tablet DRUG

3x100 mg per oral, single dose

Treatment B; Treatment C

AZD1981, new large-particle table DRUG

3x100 mg per oral, single dose in fasted state

Treatment D

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male and postmenopausal or surgically sterile female volunteers aged 18-55, inclusive
• Have a body mass index between 19-30 kg/m2 and weigh at least 50 kg and no more than 100 kg, inclusive
• Be a non-smoker or ex-smoker who has stopped smoking for \>6 months prior to screening
• Volunteers must be willing to use barrier methods of contraceptive, unless their partners are post-menopausal, surgically sterile or using accepted contraceptive methods.

You may not qualify if:

• Any clinically significant disease or disorder
• Any clinically relevant abnormal findings in the physical examination, clinical chemistry, haematology, urinalysis, vital signs (including body temperature), or ECG assessments at Visit 1, or in vital signs (including body temperature) at Visit 2
• Prolonged QTcF \>450 ms or shortened QTcF\<340 ms at Visit 1 or family history of long QT syndrome
• History of, or current alcohol or drug abuse

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Uppsala, Sweden

Location

MeSH Terms

Interventions

AZD1981

Study Officials

• Wolfgang Kühn, MD

  Quintiles AB, Phase 1 Services

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 3, 2011
• First Posted: March 9, 2011
• Study Start: April 1, 2011
• Primary Completion: May 1, 2011
• Study Completion: June 1, 2011
• Last Updated: July 7, 2011

Record last verified: 2011-07

Locations

SE (1)