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Study in Healthy Volunteers to Investigate the Effects of Rifampin on the Pharmacokinetics of NKTR-118

Primary Purpose

Drug Induced Constipation

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

NKTR-118

Rifampin

About this trial

This is an interventional basic science trial for Drug Induced Constipation focused on measuring Phase 1, Healthy male and female volunteers, Drug-drug interaction, Pharmacokinetics, NKTR-118, Bioavailability, Plasma AUC and Cmax, Plasma AUC0-t and t1/2λz and tmax

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Provision of signed and dated, written informed consent prior to any study-specific procedures.
Male and female (nonchildbearing potential, nonlactating) healthy volunteers aged 18 to 55 years inclusive, with suitable veins for cannulation or repeated venipuncture.
Female volunteers must have a negative pregnancy test at screening and at admission, must not be lactating, and must be of nonchildbearing potential.
Male volunteers should be willing to use barrier contraception ie, condoms, from the first day of dosing until 3 months after dosing with the IP. The female partner should use contraception during this period.
Volunteers must have a BMI between 18 and 30 kg/m2, inclusive, and weigh at least 50 kg.

Exclusion Criteria:

Any clinically significant disease or disorder (eg, cardiovascular, pulmonary, gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic, malignant, psychiatric, or major physical impairment), as judged by the Investigator.
Any clinically significant illness, medical/surgical procedure or trauma, in the opinion of the Investigator, within 4 weeks of the first administration of IP.
Any clinically significant abnormalities in clinical chemistry, hematology, or urinalysis results as judged by the Investigator.
Significant orthostatic reaction at enrollment as judged by the Investigator.
Abnormal vital signs, after 10 minutes supine rest as defined in protocol.

Sites / Locations

Research Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

NKTR-118

Rifampin

Rifampin/ NKTR-118

Arm Description

Single dose NKTR-118 25 mg on Day 1 only

Rifampin 600 mg once daily on Days 4 to 12

Rifampin 600 mg plus NKTR-118 25 mg on Day 13

Outcomes

Primary Outcome Measures

Description of the pharmacokinetic(PK) profile for NKTR 118 after co administration of Rifampin in terms of area under the concentration-time curve from time zero (predose) extrapolated to infinity (AUC).

Description of the PK profile for NKTR 118 in terms of maximum plasma concentration (Cmax), time to Cmax (tmax), half-life (t1/2λz), apparent terminal rate constant (λz).

Description of the PK profile for NKTR 118 in terms of area under the plasma concentration-time curve from time zero to the time of the last measurable concentration [AUC(0-t)].

Description of the PK profile for NKTR 118 in terms of area under the plasma concentration-time curve from time zero to 24 hours [AUC(0-24)].

Description of the PK profile for NKTR 118 in terms of apparent oral clearance (CL/F), and apparent volume of distribution during the terminal phase (Vz/F).

Secondary Outcome Measures

Description of the safety profile in terms of adverse events, clinical laboratory assessments , vital signs (blood pressure and pulse rate), physical examinations, electrocardiograms, and Columbia-Suicide Severity Rating scale.

Full Information

NCT ID

NCT01533870

First Posted

February 13, 2012

Last Updated

October 13, 2014

Sponsor

AstraZeneca

1. Study Identification

Unique Protocol Identification Number

NCT01533870

Brief Title

Study in Healthy Volunteers to Investigate the Effects of Rifampin on the Pharmacokinetics of NKTR-118

Official Title

An Open-label, Fixed-sequence, 3-period, 3-treatment, Crossover Study to Assess the Effects of Rifampin on Pharmacokinetics of NKTR-118 in Healthy Subjects

Study Type

Interventional

2. Study Status

Record Verification Date

October 2014

Overall Recruitment Status

Completed

Study Start Date

March 2012 (undefined)

Primary Completion Date

May 2012 (Actual)

Study Completion Date

May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AstraZeneca

4. Oversight

5. Study Description

Brief Summary

Study in healthy volunteers to investigate the effects of Rifampin on the Pharmacokinetics of NKTR-118.

Detailed Description

An Open-label, fixed-sequence, 3-period, 3-treatment, Crossover Study to Assess the Effects of Rifampin on Pharmacokinetics of NKTR-118 in Healthy Subjects.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Drug Induced Constipation

Keywords

Phase 1, Healthy male and female volunteers, Drug-drug interaction, Pharmacokinetics, NKTR-118, Bioavailability, Plasma AUC and Cmax, Plasma AUC0-t and t1/2λz and tmax

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

22 (Actual)

8. Arms, Groups, and Interventions

Arm Title

NKTR-118

Arm Type

Experimental

Arm Description

Single dose NKTR-118 25 mg on Day 1 only

Arm Title

Rifampin

Arm Type

Active Comparator

Arm Description

Rifampin 600 mg once daily on Days 4 to 12

Arm Title

Rifampin/ NKTR-118

Arm Type

Active Comparator

Arm Description

Rifampin 600 mg plus NKTR-118 25 mg on Day 13

Intervention Type

Drug

Intervention Name(s)

NKTR-118

Intervention Description

Oral 25 mg

Intervention Type

Drug

Intervention Name(s)

Rifampin

Intervention Description

Oral 600 mg

Primary Outcome Measure Information:

Title

Time Frame