Auranofin PK Following Oral Dose Administration

NCT02089048 | Completed Phase 1 FDA Drug

• 2 other identifiers: 12-0101HHSN272200800024C
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Amoebiasis

Keywords

Amebiasis; auranofin; pharmacodynamics; pharmokinetics

Outcome Measures

Primary Outcomes (1)

• Plasma concentrations of gold following 7 once daily doses of auranofin

  Up to Day 126

Secondary Outcomes (2)

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

  Up to Day 126

• Type, frequency and severity of treatment-emergent adverse events (TEAEs) to 14 days after administration of the first dose

  14 Days after first dose

Study Arms (1)

Cohort 1

EXPERIMENTAL

15 subjects receive 6mg of auranofin once every 24 hours for 7 days

Drug: Auranofin

Interventions

Auranofin DRUG

Auranofin is a gold-containing chemical salt available as 3mg capsules. Cohort 1 receives 6mg oral dose of auranofin once every 24 hours for 7 days

Cohort 1

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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 \</= 2 basal cell and/or squamous cell carcinomas of the skin completely excised) in the 5 years prior to Day -1 with no evidence of recurrence. -Breastfeeding or a positive serum pregnancy test at the Screening Visit or Day -1. -History of drug abuse within 6 months prior to study drug administration. -A history of alcohol abuse, defined as regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for men (1 drink = 5 ounces \[150 mL\] of wine or 12 ounces \[360 mL\] of beer or 1.5 ounces \[45 mL\] of hard liquor), within 6 months prior to study drug administration. -Positive results from a standard urine drug screen (Screening Visit or Day -1) or a positive test for alcohol (Screening visit or Day -1). -Daily use of tobacco- or nicotine-containing products (cigarettes, pipe, cigar, chewing tobacco or nicotine gum, lozenges or patches). Occasional social smoking is acceptable. You must not change your use of tobacco from your first visit and through completion of the last visit of the study. -Treatment with an investigational drug within 30 days prior to study drug administration. -Prior exposure to gold-containing products. -Use of any prescription or nonprescription drugs, vitamins, or dietary or herbal supplements within 14 days prior to study drug administration. As exceptions, acetaminophen may be used at doses of \</=1 g/day until 24 hours prior to study drug administration. -Blood donation of \>/= 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.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

Quintiles Phase I Services - Overland Park

Overland Park, Kansas, 66211-1553, United States

Location

Related Publications (1)

• Capparelli EV, Bricker-Ford R, Rogers MJ, McKerrow JH, Reed SL. Phase I Clinical Trial Results of Auranofin, a Novel Antiparasitic Agent. Antimicrob Agents Chemother. 2016 Dec 27;61(1):e01947-16. doi: 10.1128/AAC.01947-16. Print 2017 Jan.

  PMID: 27821451 DERIVED

MeSH Terms

Conditions

Amebiasis

Interventions

Auranofin

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections

Intervention Hierarchy (Ancestors)

Aurothioglucose; Organogold Compounds; Organometallic Compounds; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2014
• First Posted: March 17, 2014
• Study Start: April 2, 2014
• Primary Completion: September 9, 2014
• Study Completion: May 13, 2015
• Last Updated: April 28, 2017

Record last verified: 2014-03-12

Locations

US (1)