Assessment of Relative Bioavailability of NKTR-118 in Three Formulations in Healthy Subjects

NCT ID: NCT01365000

Last Updated: 2014-10-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2011-08-31

Brief Summary

The is an assessment of Relative Bioavailability of NKTR-118 in Three Formulations in Healthy Subjects.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

NKTR118 Formulation 1

Fasted

Group Type: EXPERIMENTAL

NKTR118 Formulation 1

Intervention Type: DRUG

Oral dose, 25 mg

NKTR118 Formulation 2

Fasted

Group Type: EXPERIMENTAL

NKTR118 Formulation 2

Intervention Type: DRUG

Oral dose, 25 mg

NKTR118 Formulation 3

Fasted

Group Type: EXPERIMENTAL

NKTR118 Formulation 3

Intervention Type: DRUG

Oral dose, 25 mg

NKTR118 Formulation 1a

Fed

Group Type: EXPERIMENTAL

NKTR118 Formulation 1a

Intervention Type: DRUG

Oral dose, 25 mg

NKTR118 Formulation 3a

FED

Group Type: EXPERIMENTAL

NKTR118 Formulation 3a

Intervention Type: DRUG

Oral dose, 25 mg

Interventions

NKTR118 Formulation 1

Oral dose, 25 mg

Intervention Type: DRUG

NKTR118 Formulation 2

Oral dose, 25 mg

Intervention Type: DRUG

NKTR118 Formulation 3

Oral dose, 25 mg

Intervention Type: DRUG

NKTR118 Formulation 1a

Oral dose, 25 mg

Intervention Type: DRUG

NKTR118 Formulation 3a

Oral dose, 25 mg

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Provision of signed and dated, written informed consent prior to any study-specific procedures
• Females must have a negative pregnancy test at screening and on admission to the unit, must not be lactating, and must be of non-childbearing potential, confirmed at screening by fulfilling one of the following criteria:
• Post-menopausal defined as amenorrhea for at least 12 months following cessation of all exogenous hormonal treatments and with follicle stimulating hormone (FSH) levels in the laboratory defined post-menopausal range
• Irreversible surgical sterilization by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy, but not tubal ligation
• Volunteers must have a body mass index (BMI) between 18 and 30 kg/m2 and weigh at least 50 kg
• Volunteers must be able to understand and be willing to comply with study procedures, restrictions and requirements
• Healthy male and non-fertile female volunteers ages 18 to 55 years inclusive, with suitable veins for cannulation or repeated venipuncture

Exclusion Criteria

• Any clinically significant disease or disorder (eg, cardiovascular, pulmonary, gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic, malignant, psychiatric, major physical impairment) which, in the opinion of the Investigator, may either put the healthy volunteer at risk because of participation in the study, or influence the absorption, distribution, metabolism, and excretion of drugs
• Current smokers, those who have smoked or used nicotine products within the previous 3 months from the date of screening (Visit 1)
• Plasma donation within 1 month of screening or any blood donation/blood loss >500 mL during the 3 months prior to screening or intention to donate blood or blood products during the study or within 3 months after the completion of the study
• Positive screen for drugs of abuse, or cotinine (nicotine level above 400 ng/mL), at screening or admission and/or positive alcohol test at admission
• Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of investigational product

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mark Sostek, MD

Role: STUDY_DIRECTOR

AstraZeneca

David Mathews, MD

Role: PRINCIPAL_INVESTIGATOR

Quintiles, Inc.

Locations

Research Site

Overland Park, Kansas, United States

Countries

United States

Related Links

http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=1399&filename=D3820C00025_Clinical_Study_Report_Synopsis.pdf

D3820C00025 Clinical Study Report Synopsis

Other Identifiers

D3820C00025

Identifier Type: -

Identifier Source: org_study_id