Bioavailability and Effect of Food on DSM265 Granules in Healthy Adult Subjects



Status:Recruiting
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 55
Updated:6/23/2016
Start Date:May 2016
End Date:August 2016
Contact:Kennan Marsh
Email:kennan.marsh@abbvie.com
Phone:+1 847 937 0841

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An Assessment of the Bioavailability and Effect of Food on DSM265 Granules in Healthy Adult Subjects

This is a single-dose, fasting and non-fasting, open-label, randomized, three-regimen,
parallel group study in 42 subjects

This is a randomized, open label, single dose, parallel group study consisting of 3 groups
of 14 subjects each. Subjects will be confined for 3 days followed by outpatient assessments
until Day 21. Blood samples for assessment of DSM265 plasma concentrations will be collected
for 480 hours after dosing.

This study will compare the relative bioavailability of the oral DSM265 50% spray dried
dispersion (SDD) granules with that of a reference 25% SDD powder for suspension
formulation, and evaluate the effect of food on the DSM265 50% SDD granules

Inclusion Criteria:

- Female subjects of non-child bearing potential:

- surgically sterile (by hysterectomy and/or bilateral oophorectomy and/or
bilateral salpingectomy or bilateral tubal ligation) OR

- postmenopausal (without use of hormonal contraceptive and spontaneous amenorrhea
for 12 months and follicle stimulating hormone > 40 IU/mL age appropriate for
menopause and no other medical explanation for amenorrhea)

- Males:

- If he (including those who have had a vasectomy) is sexually active with female
partner(s) of childbearing potential, he must agree, from Day 1 through 120 days
after the dose of study drug to practice the continuous acceptable methods of
contraception with his partner(s).

- If he has a female partner who is postmenopausal or permanently sterile, the
male subject must agree to use condoms from Day 1 through 120 days after the
dose of study drug

- Females must have negative pregnancy tests:

- at Screening within 28 days prior to initial study drug administration, and

- prior to dosing on Study Day -1

- Body Mass Index at least 18.0 and less than / equal to 29.9. Body weight must be >50
kg

- General good health, based on medical history, physical examination, vital signs,
laboratory profile and Electrocardiogram

- Voluntarily sign and date each informed consent, approved by an Institutional Review
Board, prior to any screening or study procedures

Exclusion Criteria:

- Female who is pregnant, breastfeeding or is considering becoming pregnant during the
study or for approximately 60 days after the dose of study drug

- Male who is considering fathering a child or donating sperm during the study or for
120 days after the last dose of study drug

- History of significant sensitivity to any drug

- History of epilepsy, any clinically significant cardiac, respiratory, renal, hepatic,
gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled
medical illness

- History of gastric surgery (except phyloromoyotomy for pyloric stenosis during
infancy), vagotomy, bowel resection or any surgical procedure that might interfere
with gastrointestinal motility, pH or absorption

- Requirement for any over-the-counter or prescription medication, vitamins or herbal
supplements, except contraceptives or hormone replacement therapy for females, on a
regular basis

- Use of any medication, vitamins / herbal supplements except contraceptives or hormone
replacement therapy for females, within 2 weeks prior to study drug administration or
within 5 half-lives, whichever is longer

- Receipt of any drug by injection within 30 days or 5 half-lives, whichever is longer,
prior to study drug administration, except parenteral hormonal contraceptives for
females

- Receipt of any investigational product within 6 weeks prior to study drug
administration or 5 half-lives, whichever is longer

- Recent (6-month) history of drug or alcohol abuse

- Consumption of alcohol within 72 hours prior to study drug administration

- Consumption of grapefruit or grapefruit products, Seville oranges, starfruit, or
products containing any of these ingredients, and/or quinine/tonic water from 7 days
prior to study drug administration

- Use of tobacco or nicotine-containing products within 6 months before study drug
administration

- Positive for hepatitis A virus immunoglobulin M, hepatitis B surface antigen or
hepatitis C virus antibody or HIV antibodies. Negative HIV status will be confirmed
at Screening and results will be maintained confidentially

- Positive screen for drugs of abuse, or alcohol or cotinine or positive and clinically
significant urine adulterants test

- Donation or loss of 550 mL or more blood volume (including plasmapheresis) or receipt
of a transfusion of any blood product in 8 weeks prior to study drug administration

- Current enrollment in another clinical study

- Previous enrollment in this study

- Consideration by the investigator, for any reason, that the subject is an unsuitable
candidate to receive DSM265
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