To Determine the Relative Bioavailability of Different Formulations of AZD9291 and the Effect of Food.

NCT01951599 | Completed Phase 1

• 1 other identifier: D5160C00005
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

To determine the relative bioavailability of different oral formulations of AZD9291 and the effect of food in healthy volunteers.

Conditions

Healthy Volunteers

Keywords

Phase I, healthy, bioavailability, pharmacokinetics, safety, tolerability.

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetics of AZD9291 and its metabolites, by assessment of maximum plasma concentration (Cmax)

  Curve taken during each of the 5 treatments

  Blood samples are collected pre dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336, 504 hours post dose

Secondary Outcomes (10)

• Pharmacokinetics of AZD9291 and its metabolites by assessment of the area under the plasma concentration-time curve from zero to infinity (AUC)

  Blood samples are collected pre dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336, 504 hours post dose

• Pharmacokinetics of AZD9291 and its metabolites, by assessment of time to Cmax (tmax)

  Blood samples are collected pre dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336, 504 hours post dose

• Pharmacokinetics of AZD9291 and its metabolites, by assessment of Terminal rate constant (λz)

  Blood samples are collected pre dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336, 504 hours post dose

• Pharmacokinetics of AZD9291 and its metabolites, by assessment of Terminal half life (t1/2,λz)

  Blood samples are collected pre dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336, 504 hours post dose

• Pharmacokinetics of AZD9291 and its metabolites, by assessment of lag time before observation of quantifiable analyte concentrations in plasma (tlag)

  Blood samples are collected pre dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336, 504 hours post dose

Other Outcomes (1)

• Safety variables (adverse events, physical exam, vital signs, ECG's, clinical laboratory safety tests, opthalmological examination)

  Baseline (Day-1) to Day 28

Study Arms (5)

AZD9291 20mg (oral capsule fasted)

EXPERIMENTAL

Volunteers will receive AZD9291 20mg administered by mouth, as a capsule, in the fasted state.

Drug: AZD9291

AZD9291 20mg (oral solution fasted)

EXPERIMENTAL

Volunteers will receive AZD9291 20mg administered by mouth, as a solution, in the fasted state.

Drug: AZD9291

AZD9291 20mg (oral tablet fasted)

EXPERIMENTAL

Volunteers will receive AZD9291 20mg administered by mouth, as a tablet, in the fasted state.

Drug: AZD9291

AZD9291 20mg (oral fasted)

EXPERIMENTAL

Volunteers will receive AZD9291 20mg administered by mouth, as a capsule or tablet in the fasted state.

Drug: AZD9291

AZD9291 20mg (oral fed)

EXPERIMENTAL

Volunteers will receive AZD9291 20mg administered by mouth, as a capsule or tablet in the fed state.

Drug: AZD9291

Interventions

AZD9291 DRUG

Volunteers will receive a single 20-mg dose of AZD9291 as a capsule on day 1, in Part A, Period 1, in the fasted state. (Treatment A).

AZD9291 20mg (oral capsule fasted)

Eligibility Criteria

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

You may qualify if:

• , Body mass index between 19 and 30 kg/m2 and weight at least 50 kg and no more than 100 kg. 2, Volunteers must be willing to use a condom, unless their partners are postmenopausal, surgically sterile, or using an effective hormonal method of contraception or intrauterine coil. 3. In addition, volunteers must agree to continue to take similar contraceptive precautions until 4 months after the last dose of AZD9291.

You may not qualify if:

• Any clinically relevant abnormalities in physical examination, vital signs, hematology, clinical chemistry, urinalysis or ECG at baseline in the opinion of the Investigator.
• Volunteers who have received live or live-attenuated vaccine in the 2 weeks prior to dosing.
• History of severe allergy/hypersensitivity or or ongoing allergy/hypersensitivity, as judged by the Investigator, or history of hypersensitivity to AZD9291, its excipients, or drugs with a similar chemical structure or class.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Overland Park, Kansas, United States

Location

Related Links

• D5160C00005revised\_csp\_2\_signed\_31March 16\_REDACTED
• D5160C00005\_CSR\_Synopsis

MeSH Terms

Interventions

osimertinib

Study Officials

• Phil Leese, MD

  Quintiles 6700 W 115th Street, Kansas, US

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2013
• First Posted: September 26, 2013
• Study Start: October 9, 2013
• Primary Completion: June 4, 2014
• Study Completion: June 4, 2014
• Last Updated: March 31, 2017

Record last verified: 2017-03

Locations

US (1)