NCT03286829

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-administration of tesofensine plus commercial metoprolol in adult healthy subjects

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Dec 2017

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 5, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 19, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

December 18, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 6, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 6, 2018

Completed
2.3 years until next milestone

Results Posted

Study results publicly available

May 14, 2020

Completed
Last Updated

May 14, 2020

Status Verified

May 1, 2020

Enrollment Period

2 months

First QC Date

September 5, 2017

Results QC Date

April 21, 2020

Last Update Submit

May 4, 2020

Conditions

Healthy Male Subjects

Outcome Measures

Primary Outcomes (1)

  • AUC0-48

    Area under the concentration-time curve from pre-dose (time 0) to 48 hours post-dose calculated using the linear-log trapezoidal rule

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

Secondary Outcomes (2)

  • Cmax

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

  • Tmax

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

Study Arms (4)

Tesomet "High dose" in fasted condition

EXPERIMENTAL

A Tesomet FDC tablet (20 mg immediate release \[IR\] metoprolol, 1 mg tesofensine, 80 mg extended release \[ER\] metoprolol) in fasted condition ("High" dose)

Drug: Comperator 1 mg tesofensine, 25 mg commercial IR metoprolol, 75 mg commercial ER metoprolol, fasted condition.

Tesomet "Low dose" in fasted condition

EXPERIMENTAL

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)

Drug: Comperator 1 mg tesofensine, 25 mg commercial IR metoprolol, 75 mg commercial ER metoprolol, fasted condition.

Comperator

ACTIVE COMPARATOR

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

Drug: Tesomet "High dose" in fasted conditionDrug: Tesomet "Low dose" in fasted conditionDrug: Tesomet "High dose" in fed condition

Tesomet "High dose" in fed condition

EXPERIMENTAL

A Tesomet FDC tablet (20 mg immediate IR metoprolol, 1 mg tesofensine, 80 mg ER metoprolol in fed condition ("High" dose)

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

Interventions

Tesomet "High dose" in fasted conditionDRUG

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.

Also known as: Tesofensine, Metoprolol
ComperatorTesomet "High dose" in fed condition
Tesomet "Low dose" in fasted conditionDRUG

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.

Also known as: Tesofensine, Metoprolol
Comperator
Comperator 1 mg tesofensine, 25 mg commercial IR metoprolol, 75 mg commercial ER metoprolol, fasted condition.DRUG

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.

Also known as: Tesofensine, Metoprolol
Tesomet "High dose" in fasted conditionTesomet "High dose" in fed conditionTesomet "Low dose" in fasted condition
Tesomet "High dose" in fed conditionDRUG

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.

Also known as: Tesofensine, Metoprolol
Comperator

Eligibility Criteria

Age18 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Early Phase Clinical Unit;Klinikum Westend, Haus 31

Berlin, 14050, Germany

Location

MeSH Terms

Interventions

TesofensineMetoprolol

Intervention Hierarchy (Ancestors)

PhenoxypropanolaminesPropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAmines

Results Point of Contact

Title
Dr.Kim Krogsgaard, MD, DMSc, CMO
Organization
Saniona A/S
kim.krogsgaard@saniona.com
+45 20 14 83 84

Study Officials

  • Jorgen Drejer, PhD

    Saniona

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 5, 2017

First Posted

September 19, 2017

Study Start

December 18, 2017

Primary Completion

February 6, 2018

Study Completion

February 6, 2018

Last Updated

May 14, 2020

Results First Posted

May 14, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)