Trial · Interventional

CompletedPhase 1Results postedRegistry data

Study to Investigate the Pharmacokinetic Profile

NCTNCT03286829Other idTM003

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Overview

Status: Completed
Phase: Phase 1
Enrollment: 60 participants (actual)
Sponsor: Saniona · Industry
Design: Randomized · Single masking
Countries: 1 country
Germany
Start: 18 Dec 2017
Primary completion: 6 Feb 2018
Completion: 6 Feb 2018
First posted: 19 Sept 2017
Last update posted: 14 May 2020
Conditions: Healthy Male Subjects

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

201720182019

Ph 1
Study to Investigate the Pharmacokinetic Profile
NCT03286829
18 Dec 2017 to 6 Feb 2018

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

Tesomet "High dose" in fasted conditionDrug
Tesomet "Low dose" in fasted conditionDrug
Comperator 1 mg tesofensine, 25 mg commercial IR metoprolol, 75 mg commercial ER metoprolol, fasted condition.Drug
Tesomet "High dose" in fed conditionDrug

Arms4

Experimental
Tesomet "High dose" in fasted condition
A Tesomet FDC tablet (20 mg immediate release \[IR\] metoprolol, 1 mg tesofensine, 80 mg extended release \[ER\] metoprolol) in fasted condition ("High" dose)
Experimental
Tesomet "Low dose" in fasted condition
Treatment B (Test 2): A Tesomet FDC tablet (5 mg immediate IR metoprolol, 0.2 mg tesofensine, 20 mg ER metoprolol) in fasted condition. ("Low" dose)
Active comparator
Comperator
1 mg tesofensine (2 tablets of 0.5 mg), 25 mg commercial IR metoprolol (1 tablet of 25 mg), 75 mg commercial ER metoprolol (1 tablet of 25 mg ER metoprolol and 1 tablet of 50 mg ER metoprolol), fasted condition
Experimental
Tesomet "High dose" in fed condition
A Tesomet FDC tablet (20 mg immediate IR metoprolol, 1 mg tesofensine, 80 mg ER metoprolol in fed condition ("High" dose)

Primary outcomes1

Outcomes the sponsor listed as primary.

AUC0-48
Time frame · Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 30, 36 and 48 hours post-dose
Registry description
Area under the concentration-time curve from pre-dose (time 0) to 48 hours post-dose calculated using the linear-log trapezoidal rule

Secondary outcomes(2)

Cmax
Time frame · Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 30, 36 and 48 hours post-dose
Registry description
Maximum tesofensine and metoprolol concentrations determined directly from the concentration-time profile
Tmax
Time frame · Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 30, 36 and 48 hours post-dose
Registry description
Time of maximum tesofensine and metoprolol concentrations determined directly from the concentration-time profile

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeGeometric mean· Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 30, 36 and 48 hours post-dose

AUC0-48

Group	Value (ng*hr/mL)	Spread
Tesomet "High Dose" in Fasted Condition	32.06	26.9
Tesomet "Low Dose" in Fasted Condition	6.491	25.1
Comparator	45.89	21.9
Tesomet "High Dose" in Fed Condition	30.14	18.6

Secondary and other outcome results(2)

Secondary outcomeGeometric mean· Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 30, 36 and 48 hours post-dose

Cmax

Group	Value (ng/mL)	Spread
Tesomet "High Dose" in Fasted Condition	0.9528	25.5
Tesomet "Low Dose" in Fasted Condition	0.1934	23.6
Comparator	1.357	23.8
Tesomet "High Dose" in Fed Condition	0.8085	17.1

Secondary outcomeGeometric mean· Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 30, 36 and 48 hours post-dose

Tmax

Group	Value (hours)	Spread
Tesomet "High Dose" in Fasted Condition	6.12	5.98
Tesomet "Low Dose" in Fasted Condition	6.00	5.98
Comparator	6.00	3.98
Tesomet "High Dose" in Fed Condition	8.00	4.00

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Tesomet "High Dose" in Fasted ConditionA Tesomet FDC tablet (20 mg immediate release \[IR\] metoprolol, 1 mg tesofensine, 80 mg extended release \[ER\] metoprolol) in fasted condition ("High" dose)	0 / 15	0 / 15	3 / 15
Tesomet "Low Dose" in Fasted ConditionA Tesomet FDC tablet (5 mg immediate IR metoprolol, 0.2 mg tesofensine, 20 mg ER metoprolol) in fasted condition. ("Low" dose)	0 / 15	0 / 15	4 / 15
Comparator1 mg tesofensine (2 tablets of 0.5 mg), 25 mg commercial IR metoprolol (1 tablet of 25 mg), 75 mg commercial ER metoprolol (1 tablet of 25 mg ER metoprolol and 1 tablet of 50 mg ER metoprolol), fasted condition	0 / 15	0 / 15	5 / 15
Tesomet "High Dose" in Fed ConditionA Tesomet FDC tablet (20 mg immediate IR metoprolol, 1 mg tesofensine, 80 mg ER metoprolol in fed condition ("High" dose)	0 / 15	0 / 15	1 / 15

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: Male
Age: from 18 Years up to 55 Years
Healthy volunteers: Accepted

Inclusion and exclusion criteria, as posted

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.

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