A Study to Assess the Bioequivalence of R406 in Healthy Volunteers When Given 100mg and 150 mg of Fostamatinib

NCT01645085 | Completed Phase 1

• 1 other identifier: D4300C00020
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

A study in Healthy Volunteers to Compare the Amount of R406 in Blood When Given Different Formulations of Fostamatinib.

Conditions

Healthy Volunteers

Keywords

R406; Fostamatinib; Phase I; Healthy Subjects; Pharmacokinetics; Bioequivalence

Outcome Measures

Primary Outcomes (2)

• Bioequivalence of R406 when fostamatinib is administered as two 50mg MCC-based 13% drug-loaded tablets versus one 100mg mannitol-based 38% drug-loaded tablet

  Measured at predose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours postdose

• Bioequivalence of R406 when fostamatinib is administered as three 50mg MCC-based 13% drug-loaded tablets versus one 150mg mannitol-based 38% drug-loaded tablet

  Measured at predose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours postdose

Secondary Outcomes (4)

• AUC for mannitol-based 38% drug-loaded tablets and MCC-based 13% drug-loaded tablets

  Measured at predose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours postdose

• Cmax for mannitol-based 38% drug-loaded tablets and MCC-based 13% drug-loaded tablets

  Measured at predose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours postdoses

• Frequency of adverse events

  Measured throughout the study and 3 -5 days after discharge from Period 4, approximately 45 days

• Severity of adverse events

  Measured throughout the study and 3 -5 days after discharge from Period 4, approximately 45 days

Study Arms (4)

Treatment A

EXPERIMENTAL

100mg MCC-based 13% drug-loaded tablets

Drug: MCC-based 13% drug loaded tablets

Treatment B

EXPERIMENTAL

100mg mannitol-based 38% drug-loaded tablets

Drug: Mannitol-based 38% drug-loaded tablet

Treatment C

EXPERIMENTAL

150mg MCC-based 13% drug-loaded tablets

Drug: MCC-based 13% drug loaded tablets

Treatment D

EXPERIMENTAL

150mg mannitol-based 38% drug-loaded tablets

Drug: Mannitol-based 38% drug-loaded tablet

Interventions

MCC-based 13% drug loaded tablets DRUG

50mg tablets, dosed as 2 tablets (100mg total)

Treatment A

Mannitol-based 38% drug-loaded tablet DRUG

One 100mg tablet

Treatment B

Eligibility Criteria

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

You may qualify if:

• Males and nonlactating, non childbearing potential females from 18 to 55 years, inclusive and with a weight of at least 50 kg and BMI between 18 and 30 kg/m2, inclusive
• Females must have a negative pregnancy test at screening and on admission to the study center of each period, must not be lactating and must be of non childbearing potential
• Non childbearing potential can be confirmed by being postmenopausal defined as amenorrhea for a least 12 months following cessation of all exogenous hormonal treatments and with FSH and LH levels in the laboratory-defined postmenopausal range
• Non childbearing potential can be confirmed by documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy but not tubal ligation.

You may not qualify if:

• History of any clinically significant disease or disorder, including GI, hepatic or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs
• Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody, and human immunodeficiency virus (HIV) antibody
• Known or suspected history of drug abuse, as judge by the investigator
• Any clinically significant abnormalities on 12-lead ECG as judged by the Investigator
• Current smokers, or those who have smoked, used nicotine-containing products, or used smoking cessation treatments within the previous 1 month prior to enrollment

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Unknown Facility

Overland Park, Kansas, United States

Location

Study Officials

• Chris O'Brien, MEDICAL SCIENCE DIRECTOR

  AstraZeneca

  STUDY DIRECTOR

• David Mathews, MD

  Quintiles, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: July 13, 2012
• First Posted: July 20, 2012
• Study Start: July 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: March 19, 2013

Record last verified: 2013-03

Locations

US (1)