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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01533870
First received: February 13, 2012
Last updated: December 11, 2012
Last verified: December 2012

February 13, 2012
December 11, 2012
March 2012
May 2012   (final data collection date for primary outcome measure)
  • 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). [ Time Frame: Predose and at 0:15, 0:30, 1, 1:30, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours Day 1 and 13 ] [ Designated as safety issue: No ]
  • 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). [ Time Frame: Predose and at 0:15, 0:30, 1, 1:30, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours Day 1 and 13 ] [ Designated as safety issue: No ]
  • 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)]. [ Time Frame: Predose and at 0:15, 0:30, 1, 1:30, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours Day 1 and 13 ] [ Designated as safety issue: No ]
  • 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)]. [ Time Frame: Predose and at 0:15, 0:30, 1, 1:30, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours Day 1 and 13 ] [ Designated as safety issue: No ]
  • 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). [ Time Frame: Predose and at 0:15, 0:30, 1, 1:30, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours Day 1 and 13 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01533870 on ClinicalTrials.gov Archive Site
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. [ Time Frame: From baseline day -1 through to Follow-up (Maximum 27 days) ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Study in Healthy Volunteers to Investigate the Effects of Rifampin on the Pharmacokinetics of NKTR-118
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 in healthy volunteers to investigate the effects of Rifampin on the Pharmacokinetics of NKTR-118.

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.

Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Drug Induced Constipation
  • Drug: NKTR-118
    Oral 25 mg
  • Drug: Rifampin
    Oral 600 mg
  • Experimental: NKTR-118
    Single dose NKTR-118 25 mg on Day 1 only
    Intervention: Drug: NKTR-118
  • Active Comparator: Rifampin
    Rifampin 600 mg once daily on Days 4 to 12
    Intervention: Drug: Rifampin
  • Active Comparator: Rifampin/ NKTR-118
    Rifampin 600 mg plus NKTR-118 25 mg on Day 13
    Interventions:
    • Drug: NKTR-118
    • Drug: Rifampin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
22
May 2012
May 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01533870
D3820C00015
Not Provided
AstraZeneca
AstraZeneca
Not Provided
Study Chair: Bo Fransson, MD AstraZeneca, Sodertalje Sweden
Principal Investigator: Kelli Craven, MD Quintiles, Inc Kansas Overland Park US.
Study Director: Mark Sostek, MD AstraZeneca, Wilmington US
AstraZeneca
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP