Phase 1 Study to Evaluate ASN002 Absorption, Metabolism, and Excretion of [14C] Following a Single Oral Dose in Healthy Male Subjects
Status: | Completed |
---|---|
Conditions: | Healthy Studies |
Therapuetic Areas: | Other |
Healthy: | No |
Age Range: | 20 - 60 |
Updated: | 11/3/2018 |
Start Date: | October 11, 2018 |
End Date: | October 21, 2018 |
A Phase 1, Open-label Study of the Absorption, Metabolism, and Excretion of [14C] ASN002 Following a Single Oral Dose in Healthy Male Subjects
Phase 1, Open-label Study of the Absorption, Metabolism, and Excretion of [14C] ASN002
Following a Single Oral Dose in Healthy Male Subjects
Following a Single Oral Dose in Healthy Male Subjects
This will be a Phase 1, open-label, nonrandomized, single-dose study in healthy male
subjects. Subjects will be admitted into the Clinical Research Unit (CRU) on Day 1 and be
confined to the CRU until at least Day 7. On Day 1, subjects will receive a single oral dose
of [14C] ASN002 at 60 mg containing approximately 300 μCi [14C] ASN002. Subjects will be
discharged on Day 7 if the following discharge criteria are met: plasma radioactivity levels
below the limit of quantitation for 2 consecutive collections, and ≥90% mass balance
recovery, or ≤1% of the total radioactive dose is recovered in combined excreta (urine and
feces) in 3 consecutive 24 hour periods. If discharge criteria are not met by Day 7, subjects
will remain in the CRU up to a maximum of Day 10.
subjects. Subjects will be admitted into the Clinical Research Unit (CRU) on Day 1 and be
confined to the CRU until at least Day 7. On Day 1, subjects will receive a single oral dose
of [14C] ASN002 at 60 mg containing approximately 300 μCi [14C] ASN002. Subjects will be
discharged on Day 7 if the following discharge criteria are met: plasma radioactivity levels
below the limit of quantitation for 2 consecutive collections, and ≥90% mass balance
recovery, or ≤1% of the total radioactive dose is recovered in combined excreta (urine and
feces) in 3 consecutive 24 hour periods. If discharge criteria are not met by Day 7, subjects
will remain in the CRU up to a maximum of Day 10.
Inclusion Criteria:
- Males, of any race, between 20 and 60 years of age, inclusive, at Screening.
- Body mass index between 18.5 and 30.0 kg/m2, inclusive, at Screening.
- In good health, determined by no clinically significant findings from medical history,
physical examination, 12 lead ECG, vital signs measurements, and clinical laboratory
evaluations (congenital nonhemolytic hyperbilirubinemia [eg, Gilbert's syndrome] is
not acceptable) at Screening or Check in as assessed by the Investigator (or
designee).
- Males will agree to use contraception as defined in the Protocol body
- Able to comprehend and willing to sign an ICF and to abide by the study restrictions.
- History of a minimum of 1 bowel movement per day.
Exclusion Criteria:
- Significant history or clinical manifestation of any metabolic, allergic,
dermatological, hepatic, renal, hematological, pulmonary, cardiovascular,
gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as
determined by the Investigator (or designee).
- History of significant hypersensitivity, intolerance, or allergy to any drug compound,
food, or other substance, unless approved by the Investigator (or designee).
- History of stomach or intestinal surgery or resection that would potentially alter
absorption and/or excretion of orally administered drugs (uncomplicated appendectomy
and hernia repair will not be allowed).
- History of alcoholism or drug/chemical abuse within 2 years prior to Check in.
- Consumption of alcohol from 72 hours prior to Check-in until Discharge.
- Consumption of foods and beverages containing poppy seeds, grapefruit, or Seville
oranges from 7 days prior to Check-in until Discharge.
- Consumption of caffeine containing foods and beverages from 48 hours before Check-in
until Discharge.
- Positive urine drug screen (including cotinine) at Screening or positive alcohol
breath test or positive urine drug screen (including cotinine) at Check in.
- Positive hepatitis panel and/or positive human immunodeficiency virus test.
- Participation in a clinical study involving administration of an investigational drug
(new chemical entity) in the past 30 days or 5 half-lives (if known), whichever is
longer, prior to Check-in.
- Use or intend to use any medications/products known to alter drug absorption,
metabolism, or excretion processes, including St. John's wort, within 14 days prior to
Check in, unless deemed acceptable by the Investigator (or designee).
- Use or intend to use any prescription medications/products within 14 days prior to
Check in, unless deemed acceptable by the Investigator (or designee).
- Use or intend to use slow release medications/products considered to still be active
within 14 days prior to Check in, unless deemed acceptable by the Investigator (or
designee).
- Use or intend to use any nonprescription medications/products including vitamins,
minerals, and phytotherapeutic/herbal/plant derived preparations within 7 days prior
to Check in, unless deemed acceptable by the Investigator (or designee).
- Use of tobacco or nicotine containing products within 3 months prior to Check in.
- Receipt of blood products within 2 months prior to Check in.
- Donation of blood from 56 days prior to Screening, plasma from 2 weeks prior to
Screening, or platelets from 6 weeks prior to Screening.
- Poor peripheral venous access.
- Have previously completed or withdrawn from this study or any other study
investigating ASN002, and have previously received the investigational medicinal
product (IMP).
- Subjects with exposure to significant diagnostic or therapeutic radiation (eg, serial
X ray, computed tomography scan, barium meal) or current employment in a job requiring
radiation exposure monitoring within 12 months prior to Check-in.
- Subjects who have participated in a radiolabeled drug study where exposures are known
to the Investigator within the previous 4 months prior to admission to the clinic for
this study or participated in a radiolabeled drug study where exposures are not known
to the Investigator within the previous 6 months prior to admission to the clinic for
this study. The total 12-month exposure from this study and a maximum of 2 other
previous radiolabeled studies within 4 to 12 months prior to this study will be within
the CFR recommended levels considered safe, per United States Title 21 CFR 361.1: less
than 5,000 mrem whole body annual exposure with consideration given to the half-lives
of the previous radiolabeled study drugs received.
- Subjects who, in the opinion of the Investigator (or designee), should not participate
in this study.
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