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

Purpose

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

Condition	Intervention	Phase
Healthy	Drug: NKTR118 Formulation 1 Drug: NKTR118 Formulation 2 Drug: NKTR118 Formulation 3 Drug: NKTR118 Formulation 1a Drug: NKTR118 Formulation 3a	Phase 1

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

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Pharmacokinetics after a dose of NKTR-118 25 mg by assessment of (Cmax) [ Time Frame: day-1 to day 3 ] [ Designated as safety issue: No ]
Pharmacokinetics after a dose of NKTR-118 25 mg by assessment of time to Cmax (tmax) [ Time Frame: day-1 to day 3 ] [ Designated as safety issue: No ]
Pharmacokinetics after a dose of NKTR-118 25 mg by assessment of half-life (t1/2λz) [ Time Frame: day-1 to day 3 ] [ Designated as safety issue: No ]
Pharmacokinetics after a dose of NKTR-118 25 mg by assessment of area under concentration-time curve (AUC(0-t)) [ Time Frame: day-1 to day 3 ] [ Designated as safety issue: No ]
Pharmacokinetics after a dose of NKTR-118 25 mg by assessment of area from time zero (pre-dose) extrapolated to infinity (AUC). [ Time Frame: day-1 to day 3 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety and tolerability of NKTR-118 following administration of a single oral doses of NKTR-118 of 3 different formulations during fed and fasted conditions by assessing adverse events [ Time Frame: Duration day -1 (Visit 2) to follow up (Visit 12) ] [ Designated as safety issue: Yes ]
Safety and tolerability of NKTR-118 following administration of a single oral doses of NKTR-118 of 3 different formulations during fed and fasted conditions by assessing Safety Laboratory values [ Time Frame: Duration day -1 (Visit 2) to follow up (Visit 12) ] [ Designated as safety issue: Yes ]
Safety and tolerability of NKTR-118 following administration of a single oral doses of NKTR-118 of 3 different formulations during fed and fasted conditions by assessing 12-Lead Electrocardiograms [ Time Frame: Duration day -1 (Visit 2) to follow up (Visit 12) ] [ Designated as safety issue: Yes ]
Safety and tolerability of NKTR-118 following administration of a single oral doses of NKTR-118 of 3 different formulations during fed and fasted conditions by assessing Columbia-Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Duration day -1 (Visit 2) to follow up (Visit 12) ] [ Designated as safety issue: Yes ]
Concentration of NKTR-118 in plasma samples after drug intake during Fed condition [ Time Frame: Duration: Day 1 to day 4 at the 2 last inhouse stays ] [ Designated as safety issue: No ]

Enrollment:	21
Study Start Date:	June 2011
Study Completion Date:	August 2011
Primary Completion Date:	August 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: NKTR118 Formulation 1 Fasted	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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01365000

Locations

United States, Kansas
Research Site
Overland Park, Kansas, United States

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:	Mark Sostek, MD	AstraZeneca
Principal Investigator:	David Mathews, MD	Quintiles

More Information

No publications provided

Responsible Party:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT01365000 History of Changes
Other Study ID Numbers:	D3820C00025
Study First Received:	May 31, 2011
Last Updated:	August 24, 2011
Health Authority:	United States: Food and Drug Administration United States: Institutional Review Board

Keywords provided by AstraZeneca:

Phase 1
Pharmacokinetics
NKTR-118
fasting or fed state
cross-over study

AUC(0-t)
Cmax
tmax
QTcF Interval

ClinicalTrials.gov processed this record on May 16, 2013