A Metabolite Identification, Mass Balance, and PK Study of [14C]-Asimadoline to Healthy Adult Male Volunteers

NCT ID: NCT01380561

Last Updated: 2011-10-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2011-07-31

Brief Summary

This is an open label, single center, metabolite identification, mass balance, and PK study in healthy male volunteers.

Detailed Description

This is an open label, single center, metabolite identification, mass balance, and PK study in healthy male volunteers. The purposes of this study is to determine the excretion of total [14C] derived radioactivity and the metabolite profile after a single oral dose of [14C] asimadoline as well as to identify and quantitate the metabolites of asimadoline in plasma, urine, and feces after single and multiple oral doses of asimadoline.

Conditions

Healthy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Single Arm Study

asimadoline

Group Type: EXPERIMENTAL

asimadoline

Intervention Type: DRUG

10mg \[14\]C labelled asimadoline Day 1 then 7 doses 0.5 mg asimadoline bid beginning on Day 2 and ending on Day 5.

Interventions

asimadoline

10mg \[14\]C labelled asimadoline Day 1 then 7 doses 0.5 mg asimadoline bid beginning on Day 2 and ending on Day 5.

Intervention Type: DRUG

Other Intervention Names

EMD 61 753; EMR 63 320

Eligibility Criteria

Inclusion Criteria

• Be informed of the nature of the study and have provided written informed voluntary consent
• Be healthy males, at least 18 years of age or the legal age of consent (whichever is greater) and less than 56 years of age
• Have a body mass index (BMI) >=18.0 and <32.0 kg/m2 and weigh at least 50 kg
• Be in good general health with no clinically relevant abnormalities based on the medical history, physical examination, clinical laboratory evaluations (hematology, clinical chemistry, urinalysis), and 12 lead electrocardiogram (ECG) that, in the opinion of the Investigator, would affect subject safety
• Agree to comply with the study procedures and restrictions.

Exclusion Criteria

• Any disease or condition that might affect drug absorption, metabolism, or excretion, or clinically significant cardiovascular, hematological, renal, hepatic, pulmonary, endocrine, gastrointestinal, immunological, dermatological, neurological, or psychiatric disease
• Receipt of a radioisotope with an effective half-life of 30 days or more within the previous 12 months
• Receipt of any diagnostic radiation procedures with an effective dose exceeding 1 rem in their lifetime
• Occupational exposure to radiation (e.g., those routinely required to wear a radiation monitoring badge)
• Receipt of any radiation treatments/therapy
• History of constipation or infrequent bowel movements (<=6 bowel movements per week on average)
• Known or suspected hypersensitivity or allergic reaction to asimadoline or similar chemical compounds or any of the components of asimadoline tablets
• Chronic use of any systemic medications (with the exception of vitamins taken at standard supplement doses); use of a drug therapy (including herbal preparations, e.g., St. John's wort) known to induce or inhibit hepatic drug metabolism within 30 days before the first dose of study medication; use of prescription medication within 14 days before administration of study medication or over-the-counter products (including natural products) within 7 days before administration of study medication, except for topical products without systemic absorption, unless approved by the Sponsor
• Have smoked cigarettes or used nicotine-containing products over the last 3 months and not able to abstain from smoking for the duration of the confinement period
• If not sterile, cannot agree to use one of the following approved methods of contraception, from check-in until 3 months following Study Completion/Clinic Discharge: a male condom with spermicide; a sterile sexual partner; use by a female sexual partner of an intrauterine device with spermicide; a female condom with spermicide; contraceptive sponge with spermicide; a cervical cap with spermicide; or oral, implantable, transdermal, or injectable contraceptives with a reliable secondary back-up method
• Current history or evidence of drug or alcohol abuse or a positive screen for substances of abuse or alcohol at screening or admission
• Positive screen for hepatitis B surface antigen (HBsAg), hepatitis C antibody, or human immunodeficiency virus (HIV) antibody
• Receipt of an investigational product or device, or participation in a drug research study within a period of 30 days (or 5 half lives of the drug, whichever is longer) before the first dose of study medication
• Blood loss or blood donation of >550 mL within 90 days or plasma donation >500 mL within 30 days before administration of study drug
• Any food allergy, intolerance, restriction, or special diet that, in the opinion of the Investigator, should preclude the subject's participation in this study

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 56 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Tioga Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dr. Philip Leese

Role: PRINCIPAL_INVESTIGATOR

Quintiles Phase 1 Unit

Locations

Quintiles Phase 1 Unit

Overland Park, Kansas, United States

Countries

United States

Other Identifiers

ASMP1001

Identifier Type: -

Identifier Source: org_study_id