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

Stopped early · Phase 1

Conditions studied: Healthy Volunteers, Bioavailability

In brief

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

Key facts

Study ID

NCT02750384

Run by

Medicines for Malaria Venture

People needed

11

Starts

2016-05-01

Expected to finish

2016-07-01

Last updated by the study team

2016-09-14

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• AbbVie Clinical Pharmacology Research Unit (ACPRU) — Grayslake, Illinois, United States

Full record on ClinicalTrials.gov

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