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

NCT01365000 | Completed Phase 1

• 1 other identifier: D3820C00025
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Keywords

Phase 1; Pharmacokinetics; NKTR-118; fasting or fed state; cross-over study; AUC(0-t); Cmax; tmax; QTcF Interval

Outcome Measures

Primary Outcomes (5)

• Pharmacokinetics after a dose of NKTR-118 25 mg by assessment of (Cmax)

  day-1 to day 3

• Pharmacokinetics after a dose of NKTR-118 25 mg by assessment of time to Cmax (tmax)

  day-1 to day 3

• Pharmacokinetics after a dose of NKTR-118 25 mg by assessment of half-life (t1/2λz)

  day-1 to day 3

• Pharmacokinetics after a dose of NKTR-118 25 mg by assessment of area under concentration-time curve (AUC(0-t))

  day-1 to day 3

• Pharmacokinetics after a dose of NKTR-118 25 mg by assessment of area from time zero (pre-dose) extrapolated to infinity (AUC).

  day-1 to day 3

Secondary Outcomes (5)

• 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

  Duration day -1 (Visit 2) to follow up (Visit 12)

• 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

  Duration day -1 (Visit 2) to follow up (Visit 12)

• 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

  Duration day -1 (Visit 2) to follow up (Visit 12)

• 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)

  Duration day -1 (Visit 2) to follow up (Visit 12)

• Concentration of NKTR-118 in plasma samples after drug intake during Fed condition

  Duration: Day 1 to day 4 at the 2 last inhouse stays

Study Arms (5)

NKTR118 Formulation 1

EXPERIMENTAL

Fasted

Drug: NKTR118 Formulation 1

NKTR118 Formulation 2

EXPERIMENTAL

Fasted

Drug: NKTR118 Formulation 2

NKTR118 Formulation 3

EXPERIMENTAL

Fasted

Drug: NKTR118 Formulation 3

NKTR118 Formulation 1a

EXPERIMENTAL

Fed

Drug: NKTR118 Formulation 1a

NKTR118 Formulation 3a

EXPERIMENTAL

FED

Drug: NKTR118 Formulation 3a

Interventions

NKTR118 Formulation 1 DRUG

Oral dose, 25 mg

NKTR118 Formulation 1

NKTR118 Formulation 2 DRUG

Oral dose, 25 mg

NKTR118 Formulation 2

NKTR118 Formulation 3 DRUG

Oral dose, 25 mg

NKTR118 Formulation 3

NKTR118 Formulation 1a DRUG

Oral dose, 25 mg

NKTR118 Formulation 1a

NKTR118 Formulation 3a DRUG

Oral dose, 25 mg

NKTR118 Formulation 3a

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Overland Park, Kansas, United States

Location

Related Links

• D3820C00025 Clinical Study Report Synopsis

MeSH Terms

Conditions

Fasting

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Officials

• Mark Sostek, MD

  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: May 31, 2011
• First Posted: June 3, 2011
• Study Start: June 1, 2011
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: October 15, 2014

Record last verified: 2014-10

Locations

US (1)