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

Study identifier:D3820C00025

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Phase I, Open-label, Randomized, Balanced, Single-dose, Two-Part Study to Assess the Relative Bioavailability of NKTR-118 in Three Formulations under Fasted (3-Way crossover) and Fed (2-Way crossover) Conditions in Male and Non-fertile Female Subjects

Medical condition

Healthy

Phase

Phase 1

Healthy volunteers

Yes

Study drug

NKTR118 Formulation 1, NKTR118 Formulation 2, NKTR118 Formulation 3, NKTR118 Formulation 1a, NKTR118 Formulation 3a

Sex

All

Actual Enrollment

Study type

Interventional

Age

18 Years - 55 Years

Date

Study Start Date: 01 Jun 2011

Primary Completion Date: 01 Aug 2011

Study Completion Date: 01 Aug 2011

Study design

Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science

Verification:

Verified 01 Oct 2014 by AstraZeneca Pharmaceuticals

Collaborators

Inclusion and exclusion 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

No locations available

Arms	Assigned Interventions
Experimental: NKTR118 Formulation 1 Fasted	Drug: NKTR118 Formulation 1 Oral dose, 25 mg Drug: NKTR118 Formulation 1 Oral dose, 25 mg
Experimental: NKTR118 Formulation 2 Fasted	Drug: NKTR118 Formulation 2 Oral dose, 25 mg
Experimental: NKTR118 Formulation 3 Fasted	Drug: NKTR118 Formulation 3 Oral dose, 25 mg
Experimental: NKTR118 Formulation 1a Fed	Drug: NKTR118 Formulation 1a Oral dose, 25 mg
Experimental: NKTR118 Formulation 3a FED	Drug: NKTR118 Formulation 3a Oral dose, 25 mg

Documents available

D3820C00025 Clinical Study Report Synopsis
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information

800-236-9933

[email protected]

Contact Backup

Jeff Erickson

1 913 708-6172