Research Site
Overland Park, Kansas, United States
Completed
NCT Number: NCT01951599
To Determine the Relative Bioavailability of Different Formulations of AZD9291 and the Effect of Food.
To determine the relative bioavailability of different oral formulations of AZD9291 and the effect of food in healthy volunteers.
Completed
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Notify MeKey information
Conditions
Age range
18 year–55 year
Sex eligibility
Male
Study type
Interventional
Phase
Phase 1
Primary location
About this study
A Phase I, Open-label, Single-center, Sequential Design Study in Healthy Volunteers to Determine the Relative Bioavailability of Different Oral Formulations of AZD9291 and the Effect of Food
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
1, 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.
Exclusion criteria
- 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.
Treatment and study plan
AZD9291
DrugVolunteers 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).
Primary outcomes
-
Pharmacokinetics of AZD9291 and its metabolites, by assessment of maximum plasma concentration (Cmax)
Time frame: 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
Curve taken during each of the 5 treatments
Secondary outcomes
-
Pharmacokinetics of AZD9291 and its metabolites by assessment of the area under the plasma concentration-time curve from zero to infinity (AUC)
Time frame: 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
Curve taken during each of the 5 treatments
-
Pharmacokinetics of AZD9291 and its metabolites, by assessment of time to Cmax (tmax)
Time frame: 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
Curve taken during each of the 5 treatments
-
Pharmacokinetics of AZD9291 and its metabolites, by assessment of Terminal rate constant (λz)
Time frame: 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
Curve taken during each of the 5 treatments
-
Pharmacokinetics of AZD9291 and its metabolites, by assessment of Terminal half life (t1/2,λz)
Time frame: 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
Curve taken during each of the 5 treatments
-
Pharmacokinetics of AZD9291 and its metabolites, by assessment of lag time before observation of quantifiable analyte concentrations in plasma (tlag)
Time frame: 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
Curve taken during each of the 5 treatments
-
Pharmacokinetics of AZD9291 and its metabolites, by assessment of area under the plasma concentration-time curve from zero to time of last measurable concentration [AUC(0-t)]
Time frame: 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
Curve taken during each of the 5 treatments
-
Pharmacokinetics of AZD9291 and its metabolites, by assessment of area under the plasma concentration-time curve from zero to 72 hours [AUC(0-72)]
Time frame: 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
Curve taken during each of the 5 treatments
-
Pharmacokinetics of AZD9291 only, by assessment of apparent plasma clearance (CL/F).
Time frame: 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
Curve taken during each of the 5 treatments
-
Pharmacokinetics of AZD9291 only, apparent volume of distribution (Vz/F)
Time frame: 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
Curve taken during each of the 5 treatments
-
Pharmacokinetics of AZD9291 parent to metabolite ratio (calculated for both Cmax and AUC).
Time frame: 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
Curve taken during each of the 5 treatments
Other outcomes
-
Safety variables (adverse events, physical exam, vital signs, ECG's, clinical laboratory safety tests, opthalmological examination)
Time frame: Baseline (Day-1) to Day 28
Assessments performed during each of the 5 treatments.
Sponsors and collaborators
Lead sponsor
AstraZeneca
Industry
Registry information
Official study title
A Phase I, Open-label, Single-center, Sequential Design Study in Healthy Volunteers to Determine the Relative Bioavailability of Different Oral Formulations of AZD9291 and the Effect of Food
Important dates
- Study start
- 2013
- Primary completion
- 2014
- Study completion
- 2014
- First posted
- Sep 26, 2013
- Registry last updated
- Mar 31, 2017
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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