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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: NKTR118 Formulation 1a; Drug: NKTR118 Formulation 2; Drug: NKTR118 Formulation 3a; Drug: NKTR118 Formulation 1; Drug: NKTR118 Formulation 3

• Registration Number: NCT01365000
• Lead Sponsor: AstraZeneca

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-05-31
• Study Start: 2011-06
• Study First Submitted QC: 2011-06-01
• Study First Posted: 2011-06-03
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-13
• Last Update Posted: 2014-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
NKTR118 Formulation 1a	NKTR118 Formulation 1a	Fed
NKTR118 Formulation 2	NKTR118 Formulation 2	Fasted
NKTR118 Formulation 3a	NKTR118 Formulation 3a	FED
NKTR118 Formulation 1	NKTR118 Formulation 1	Fasted
NKTR118 Formulation 3	NKTR118 Formulation 3	Fasted

Primary Outcome Measures

Name	Time	Method
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
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 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 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

Secondary Outcome Measures

Name	Time	Method
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
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 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 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 Columbia-Suicide Severity Rating Scale (C-SSRS)	Duration day -1 (Visit 2) to follow up (Visit 12)

Trial Locations

Locations (1)

Research Site; 🇺🇸 Overland Park, Kansas, United States