Study to Investigate the Pharmacokinetic Profile
Condition: Healthy Male Subjects
Intervention: Tesomet "High dose" in fasted condition; Tesomet "Low dose" in fasted condition; Comperator 1 mg tesofensine, 25 mg commercial IR metoprolol, 75 mg commercial ER metoprolol, fasted condition.; Tesomet "High dose" in fed condition
Intervention description: To evaluate the PK profile and relative bioavailability of a single dose of the Tesomet fixed-dose combination (FDC) tablet and co-administration of tesofensine plus commercial metoprolol.; To evaluate the PK profile and relative bioavailability of a single dose of the Tesomet fixed-dose combination (FDC) tablet and co-administration of tesofensine plus commercial metoprolol.; To evaluate the PK profile and relative bioavailability of a single dose of the Tesomet fixed-dose combination (FDC) tablet and co-administration of tesofensine plus commercial metoprolol.; To evaluate the PK profile and relative bioavailability of a single dose of the Tesomet fixed-dose combination (FDC) tablet and co-administration of tesofensine plus commercial metoprolol.
Intervention MeSH terms: Metoprolol
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 60.0
Sex: Male
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

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-administration of tesofensine plus commercial metoprolol in adult healthy
      subjects
    

Eligibility criteria:

        Inclusion Criteria:

          1. 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.

          2. Males between 18 to 55 years of age, inclusive, at the Screening Visit.

          3. 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.

          4. BMI between 18.5 and 30.0 kg/m2, inclusive, at the Screening Visit.

          5. Healthy, determined by pre-study medical evaluation (medical history, physical
             examination, vital signs, 12-lead ECG and clinical laboratory evaluations).

        Exclusion Criteria:

          1. 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.

          2. Subject has any disorder that would interfere with the absorption, distribution,
             metabolism or excretion of drugs.

          3. Subject has history of alcohol and/or illicit drug abuse within 2 years of entry.

          4. Subject is unwilling to avoid consumption of coffee and caffeine-containing beverages
             within 48 hours prior to admission until discharge from the clinical site.

          5. 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.