Safety and Pharmacokinetics Study of DM1157 to Treat Malaria

Stopped early · Phase 1 · Has a placebo group

Conditions studied: Malaria

In brief

This is a phase 1 trial to evaluate the safety and pharmacokinetics of single and multiple ascending doses and effect of food on the pharmacokinetics of a novel antimalarial drug in healthy adults. The study will enroll 104 healthy volunteers, males and females, aged 18 to 45 years and will consists of 3 parts: Part 1, Single Ascending Dose (SAD); Part 2, Multiple Ascending Dose (MAD); and Part 3, Food Effect. Part 2 and Part 3 may be initiated after a Safety Monitoring Committee (SMC) review and approval of the of Part 1 safety data. Study duration will be 16 months with patient participation duration 14 days for SAD and Food Effect, and 18 days for MAD. The primary objectives of this study are to: 1) assess the safety and tolerability of single doses of DM1157 at levels ranging from 9 mg to 900 mg; 2) assess the safety and tolerability of DM1157 administered as single daily doses for 3 days at levels ranging from 150 mg to 900 mg; 3) assess the safety and tolerability of DM1157 administered with or without food.

Key facts

Study ID

NCT03490162

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

50

Starts

2018-07-31

Expected to finish

2019-09-06

Last updated by the study team

2021-07-23

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Is a healthy male or nonpregnant female age 18 to 45 years, inclusive.
• Can understand the informed consent process and procedures.
• Agrees to be available for all study visits.
• If a woman of childbearing potential, agrees to use 2 acceptable contraception methods from 30 days before first study drug administration until 90 days after last study drug administration.
• Not sterilized via tubal ligation, bilateral oophorectomy, hysterectomy, or successful Essure(R) placement (permanent, nonsurgical, nonhormonal sterilization) with documented radiological confirmation test at least 90 days after the procedure, and still menstruating or less than 1 year of the last menses if menopausal.
• - Includes, but is not limited to, nonmale sexual relationships, monogamous relationship with vasectomized partner who has been vasectomized for 180 days or more before the subject receives the first study drug dose, barrier methods such as condoms or diaphragms with spermicide or foam, effective intrauterine devices, NuvaRing(R), and licensed hormonal methods such as implants, injectables, or oral contraceptives. If sexually active, methods can include condoms, spermicidal gel, diaphragm, hormonal or nonhormonal intrauterine device, surgical sterilization, oral contraceptive pill, and depot progesterone injections.
• If male, agrees to use a barrier method of birth control from 30 days before first study drug administration until 90 days after last study drug administration.
• Has adequate venous access for blood draws.
• Body mass index (BMI) 18 to 35 kg/m\^2, inclusive.

You may not qualify if…

• Any medical disease or condition that, in the opinion of the site PI or appropriate sub investigator, is a contraindication to study participation.
• History of clinically significant ECG abnormalities or has clinically significant ECG abnormalities at Screening.
• Use of any prescription medication (excluding oral contraceptive pills in females) within 14 days before first study drug administration.
• Use of occasional nonprescription drugs (oral or topical) within 7 days before first study drug administration unless permitted by the investigator.
• Nonprescription drugs include vitamins, antacids, herbal or dietary supplements, and topical gels, creams, etc., that in the opinion of the site PI could interfere with the study drug.
• Hypertension with confirmed systolic blood pressure (BP) greater than 145 mm Hg or confirmed diastolic BP greater than 90 mm Hg, measured after 10 to 15 minutes of rest.
• Heart rate (HR) less than 50 bpm or greater than 100 bpm.
• Body weight less than 50 kg.
• History of a significant illness within 2 weeks before dosing (subjects can screen after illness is resolved for 2 weeks).
• History of hemolytic anemia.
• History of retinal eye disease.
• History of hearing loss.
• History of seizures.
• History of thyroid disease or currently on replacement therapy for hypothyroidism.
• History of liver disease other than Gilbert's syndrome.
• History of severe drug hypersensitivity, including a severe allergic reaction, anaphylaxis, or convulsions following any medication, vaccination, or infusion.
• History of malignancy except low-grade skin cancer (ex. basal cell carcinoma thought to be cured).
• Known diagnosis of prolonged QT interval, congenital long QT syndrome, bradyarrhythmias, or uncompensated heart failure.
• History of drug or alcohol abuse within 12 months before Screening.
• History of renal disease.
• Excessive consumption of beverages containing xanthine bases, including Red Bull, chocolate, etc., or more than 400 mg of caffeine per day (more than 4 cups of coffee per day).
• Consumption of citrus fruits or juices (ex. pomegranate, orange, lime, grapefruit) within 7 days before first study drug administration.
• Use of nicotine-containing products within 30 days before Screening and until completion of study.
• Consumption of alcohol within 24 hours of first study drug administration.
• Has any condition or disease that might affect drug absorption, distribution, or excretion (ex. gastrectomy, diarrhea).

Where it is running

• Duke University School of Medicine - Duke Clinical Research Institute - Duke Clinical Research Unit — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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