A Study of Pharmacokinetics, Safety and Tolerability of Dimolegin (DD217)

• Status: Completed
• Trial end date: 2018-04-25
• Target enrollment: 0
• Participant gender: Male

Summary

In the course of the clinical study, the pharmacokinetics, pharmacodynamics, safety and tolerability of Dimolegin (DD217) 10 mg enteric-coated tablets after single administration to healthy volunteers at increasing doses were studied.

24 volunteers participated in the study. The randomization procedure was carried out for 24 volunteers selected at screening. In Group 1 6 volunteers were randomized , in Group 2 6 volunteers were randomized, and in Group 3 12 volunteers were enrolled. Group 1 volunteers took the study drug at a dose of 20 mg once, group 2 volunteers took the study drug at a dose of 40 mg once, and group 3 volunteers took the study drug at a dose of 60 mg once.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: PharmaDiall Ltd.

Criteria

Inclusion Criteria:

• Male

• 18-45 years

• Verified "healthy" diagnosis based on the findings of routine clinical, laboratory, and instrumental examinations

• Body mass index (BMI) is 18.5-30.0 kg/m2

• Consent to the use of barrier contraception methods during the study period and for 3 months after it

• Written consent of the volunteer to enrollment

Exclusion Criteria:

• Aggravated allergy history

• Drug intolerance

• Acute and chronic cardiovascular, bronchopulmonary, neuroendocrine diseases as well as gastrointestinal, hepatic, renal, hematological diseases

• Systolic blood pressure less than 90 mmHg or above 130 mmHg

• Diastolic blood pressure less than 70 mmHg or above 89 mmHg

• Pulse rate less than 60 bpm or more than 89 bpm

• Gastrointestinal surgery (except for appendectomy)

• Acute infectious diseases less than 4 weeks prior to the study

• Any abnormalities detected during screening from the clinical laboratory center reference values (including estimated glomerular filtration rate (GFR), coagulation profile), clinical and instrumental study methods

• Hypersensitivity to the study product components

• Taking prescription or over-the-counter medications, including dietary supplements, herbal products, vitamins, homeopathic medicines, less than 2 weeks before the start of the study

• Administration of medicinal products with expressed effect on hemodynamics, hepatic function and other systems (e.g. barbiturates, omeprazole, cimetidine, etc.) less than 2 months prior to the study initiation

• Blood donation (≥ 450 mL of blood or plasma) less than 2 months prior to the study

• Participation in clinical studies of drug products less than 3 weeks prior to the study initiation

• Intake of more than 10 units of alcohol per week (10 mL of pure (100 %) ethanol is taken for 1 unit of alcohol, this is the amount that the body of a healthy adult breaks down within an hour; 1 unit of alcohol is equivalent to 0.33 liters of beer, 150 mL of wine or 30 mL of hard liquors), or history of alcohol or drug dependence, drug abuse

• Smoking > 10 cigarettes per day

• Positive urine drug test (cocaine, cannabis, amphetamines, barbiturates and opioids)

• Positive alcohol breath test

• Lost for follow-up during 29 days, inability to comply with the schedule of visits, inability to be hospitalized for 2.5 days

• Inability to understand or follow protocol instructions