Auranofin PK Following Oral Dose Administration

Brief Title

Auranofin PK Following Oral Dose Administration

Official Title

An Open Label, Multiple Dose Study to Evaluate the Pharmacokinetics of Auranofin Following Oral Dose Administration for 7 Days to Healthy Subjects

Brief Summary

      Phase I, open-label study in 15 healthy adult subjects receive 6 mg of auranofin orally once
      every 24 hours for 7days. Blood samples will be taken for 17 weeks following the last dose of
      auranofin for determination of terminal phase pharmacokinetic parameters. Stool samples will
      also be obtained for the measurement of gold.
    

Detailed Description

      Auranofin is a gold-containing chemical salt, granted as an orphan drug status for use in the
      treatment of amebiasis. Amebiasis is a parasitic infection caused by the protozoon Entamoeba
      histolytica. It affects about ten percent of the world's population, being especially common
      in areas with poor health infrastructure. This is a Phase I open label, multiple dose study
      to evaluate the pharmacokinetics of Auranofin following oral dose administration for 7 days
      to healthy subjects. 15 healthy male and female volunteers age 18-45 years, inclusive
      enrolled in one site. The study duration is 48 weeks and up to 23 weeks of subject
      participation. The primary objective characterizes the pharmacokinetics of gold, given as
      auranofin, during and after 7 days of once daily oral dose administration. The secondary
      objective monitor the safety of Auranofin during and after 7 days of oral administration.
    

Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

Plasma concentrations of gold following 7 once daily doses of auranofin

Secondary Outcome

 Type, frequency and severity of Serious AEs (SAEs) to the end of study

Condition

Amoebiasis

Intervention

Auranofin

Study Arms / Comparison Groups

 Cohort 1
Description:  15 subjects receive 6mg of auranofin once every 24 hours for 7 days

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

15

Start Date

April 2, 2014

Completion Date

May 13, 2015

Primary Completion Date

September 9, 2014

Eligibility Criteria

        Inclusion Criteria:

        -Personally signed and dated informed consent document. -Healthy male or female of
        non-childbearing potential, between the ages of 18 and 45 years, inclusive. Healthy is
        defined as no clinically relevant abnormalities identified by a detailed medical history,
        complete physical examination including vital signs, and clinical laboratory tests.
        Non-childbearing potential is defined as amenorrheic for at least 2 years plus a serum
        follicle-stimulating hormone (FSH) level > 30 IU/L, or documented bilateral oophorectomy
        and/or hysterectomy, or tubal ligation. -Body mass index (BMI) of 18 to 30 [weight (kg)]/
        [height (m)^2] inclusive; and a total body weight > 50 kg (110 lbs) and < 122 kg (250 lbs)
        at the Screening Visit. -Male subjects willing to use appropriate contraception for the
        duration of the study. -Willing and able to comply with scheduled visits, dosing plan,
        laboratory tests, and other study procedures.

        Exclusion Criteria:

        -Evidence or history of clinically significant hematologic, renal, endocrine, pulmonary,
        gastrointestinal, cardiovascular, hepatic, psychiatric, musculoskeletal, immunologic,
        neurologic or dermatologic disease (including drug allergies that are clinically
        significant) which in the opinion of the Investigator could impact the participation of the
        subject in the study or the assessment of the study endpoints. -Current evidence of or
        history of malignancy (excepting completely treated cervical cancer in situ or intraductal
        carcinoma of the breast, or /= 1 pint (473 mL) within 30
        days prior to study drug administration. -Plasma and platelet donation within 14 days prior
        to study drug administration. -Screening liver function tests (alanine aminotransferase
        [ALT] or aspartate aminotransferase [AST]) greater than upper limit of normal (ULN).
        -Evidence of hepatitis B, hepatitis C or human immunodeficiency virus (HIV) infection upon
        serological testing at the Screening Visit. -Evidence of active infection or febrile
        illness (e.g., bronchopulmonary, urinary or gastrointestinal) within 7 days prior to study
        drug administration. -History of allergy to auranofin or any of the excipients in the
        capsules. (excipients per the package insert of auranofin are listed in Section 6.1) -Any
        other condition that, in the opinion of the investigator, poses a risk to the safety of the
        individual or the valid conduct of the study.
      

Gender

All

Ages

18 Years - 45 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

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Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT02089048

Organization ID

12-0101

Secondary IDs

HHSN272200800024C

Responsible Party

Sponsor

Study Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)


Study Sponsor

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Verification Date

March 12, 2014