Status:
COMPLETED
Study to Investigate the Pharmacokinetic Profile
Lead Sponsor:
Saniona
Conditions:
Healthy Male Subjects
Eligibility:
MALE
18-55 years
Phase:
PHASE1
Brief Summary
A randomized, open-label, single-dose, parallel-arm, Phase 1 study to investigate the pharmacokinetic profile of a fixed-dose combination tablet of tesofensine and metoprolol (Tesomet) and co-administ...
Detailed Description
This is a randomized, open-label, parallel-arm study in 60 healthy male subjects who meet the inclusion and none of the exclusion criteria for the study. Each subject will participate in a screening p...
Eligibility Criteria
Inclusion
- Subject voluntarily agrees to participate in this study and signs an Independent Ethics Committee (IEC)-approved informed consent prior to performing any of the Screening Visit procedures.
- Males between 18 to 55 years of age, inclusive, at the Screening Visit.
- Nonsmokers (or other nicotine use) as determined by history (no nicotine use over the past 6 months) and by urine cotinine concentration (\< 500 ng/mL) at the Screening Visit and admission.
- BMI between 18.5 and 30.0 kg/m2, inclusive, at the Screening Visit.
- Healthy, determined by pre-study medical evaluation (medical history, physical examination, vital signs, 12-lead ECG and clinical laboratory evaluations).
Exclusion
- Subject has history or evidence of any clinically significant cardiovascular, gastrointestinal, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major disease or malignancy as judged by the Investigator.
- Subject has any disorder that would interfere with the absorption, distribution, metabolism or excretion of drugs.
- Subject has history of alcohol and/or illicit drug abuse within 2 years of entry.
- Subject is unwilling to avoid consumption of coffee and caffeine-containing beverages within 48 hours prior to admission until discharge from the clinical site.
- Subject is unwilling to avoid use of alcohol or alcohol-containing foods, medications or beverages, within 48 hours prior to admission until discharge from the clinical site.
Key Trial Info
Start Date :
December 18 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 6 2018
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03286829
Start Date
December 18 2017
End Date
February 6 2018
Last Update
May 14 2020
Active Locations (1)
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1
Early Phase Clinical Unit;Klinikum Westend, Haus 31
Berlin, Germany, 14050