A study to learn how the study drug elinzanetant (BAY 3427080) affects the way the drug dabigatran moves into, through and out of the body in healthy male and female participants

2022-500201-41-00 Protocol 22081 Human pharmacology (Phase I) - Other Ended

Start 2 Aug 2022 · End 15 Nov 2022 · Status Ended · 1 EU/EEA countries · 1 sites · Protocol 22081

Overview

Sponsor-declared trial summary

Phase Human pharmacology (Phase I) - Other
Status Ended
Participants planned 20
Countries 1
Sites 1

Healthy volunteers (Vasomotor Symptoms as a sex hormone-dependent disorder in women and men)

To investigate the effect of a single dose of EZN on the exposure of unconjugated and total DBG after administration of DBG etexilate

Key facts

Sponsor
Bayer Consumer Care AG, Bayer AG
Participant type
Healthy volunteers
Age range
18-64 years, 65+ years
Gender
Male and Female
Therapeutic area
Diseases [C] - Hormonal diseases [C19]
Trial duration
2 Aug 2022 → 15 Nov 2022
Decision date (initial)
2022-07-28
Transition trial
No
Low-intervention
No
Rare-disease indication
No
Vulnerable population
Yes
Funding sources
Bayer Consumer Care AG

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Pharmacokinetic

To investigate the effect of a single dose of EZN on the exposure of unconjugated and total DBG after administration of DBG etexilate

Secondary objectives 1

  1. To investigate the safety and tolerability of EZN

Conditions and MedDRA coding

Healthy volunteers (Vasomotor Symptoms as a sex hormone-dependent disorder in women and men)

VersionLevelCodeTermSystem organ class
20.0 LLT 10067819 Andropausal symptoms 10014698
21.1 LLT 10027301 Menopausal hot flushes 10038604

Study design 2 periods

#TitleAllocationBlindingRoles blindedArms
1 Period 1
Treatment Period 1: Day -1 to Day 4, with a single oral dose of 75 mg DBG etexilate in fasted state
 Not Applicable None DBG: Period 1: Subjects will receive a single oral dose of 75 mg DBG etexilate in fasted state.
2 Period 2
Treatment Period 2: Day 1 to Day 4, with a single oral dose of 120 mg EZN and 75 mg DBG etexilate (30 min after EZN) in fasted state
 Not Applicable None ENZ - DBG: Period 2: Subjects will receive a single oral dose of 120 mg EZN and 75 mg DBG etexilate (30 min after EZN) in fasted state.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

  1. Participant must be 18 to 65 years of age inclusive, at the time of signing the informed consent.
  2. Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, blood pressure (BP), pulse rate, 12-lead electrocardiogram (ECG), and laboratory tests.
  3. Body weight of at least 50 kg and body mass index (BMI) above or equal 18.0 and below or equal 30.0 kg/m² at screening.
  4. Male or female
  5. Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

Exclusion criteria 8

  1. Known hypersensitivity to any study intervention (active substances or excipients of the preparations) to be used in the study.
  2. Thyroid-stimulating hormone (TSH) outside normal range at screening.
  3. Any lesion or condition considered a significant risk factor for major bleeding.
  4. Known or suspected coagulopathies.
  5. Estimated glomerular filtration rate (eGFR according to Chronic Kidney Disease Epidemiology Collaboration; CKD-EPI) below 90 mL/min/1.73 m2 at screening.
  6. Any use of systemic or topically active medication or herbal remedies, prescription or non-prescription, within 2 weeks or 5 half-lives (whichever longer) prior to the first study intervention administration.
  7. Suspicion of drug or alcohol abuse.
  8. Smoker (current, or within 6 months before screening).

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

  1. Cmax of unconjugated and total dabigatran when given without or together with a single oral dose of EZN
  2. AUC of unconjugated and total dabigatran when given without or together with a single oral dose of EZN, or AUC(0-tlast) if AUC cannot be determined in all participants

Secondary endpoints 1

  1. Number of participants with and severity of treatment-emergent adverse events (TEAEs)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

BAY 3427080

PRD9466078 · Product

Active substance
Elinzanetant
Pharmaceutical form
CAPSULE, SOFT
Route of administration
ORAL USE
Max daily dose
120 mg milligram(s)
Max total dose
120 mg milligram(s)
Max treatment duration
1 Day(s)
Authorisation status
Not Authorised
MA holder
BAYER AG
Paediatric formulation
No
Orphan designation
No

Pradaxa 75 mg hard capsules

PRD290116 · Product

Active substance
Dabigatran Etexilate
Substance synonyms
DABIGATRANUM ETEXILATUM
Pharmaceutical form
CAPSULE, HARD
Route of administration
ORAL USE
Max daily dose
75 mg milligram(s)
Max total dose
150 mg milligram(s)
Max treatment duration
2 Day(s)
Authorisation status
Authorised
ATC code
B01AE07 — -
Marketing authorisation
EU/1/08/442/002
MA holder
BOEHRINGER INGELHEIM INTERNATIONAL GMBH
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Bayer Consumer Care AG

17 Total trials 4 Recruiting 13 Ended
Commercial
Sponsor organisation
Bayer Consumer Care AG
Address
Peter Merian-Strasse 84
City
Basel Town
Postcode
4052
Country
Switzerland

Scientific contact point

Organisation
Bayer AG
Contact name
Bayer Clinical Trials Contact

Public contact point

Organisation
Bayer AG
Contact name
Bayer Clinical Trials Contact

Third parties 2

OrganisationCity, countryDuties
CRS Clinical Research Services Management GmbH
ORG-100039537
 Wuppertal, Germany Code 11, Other
ClinAssess Gesellschaft fuer Klinische Forschung mbH
ORG-100009848
 Leverkusen, Germany On site monitoring

Bayer AG

71 Total trials 15 Recruiting 52 Ended
Commercial
Sponsor organisation
Bayer AG
Address
51368
City
Leverkusen
Country
Germany

Sponsor responsibilities

Article 77 compliance
Bayer Consumer Care AG
Article 77 implementation
Bayer Consumer Care AG

Locations

1 EU/EEA country · 1 investigational sites

By country

CountryMS statusPlanned subjectsSites
Germany Ended 20 1
Rest of world — 0 —

Investigational sites

Germany

1 site · Ended
CRS Clinical Research Services Management GmbH
Clinical Pharmacology Unit, Aprather Weg 18a, Uellendahl-Katernberg, Wuppertal

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country Trial startTrial end Recruitment startRecruitment end Early termination
Germany 2022-08-02 2022-11-14 2022-08-05 2022-08-22

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Summary of results Art. 37(4) CTR

TitleSubmission dateStatusType
CTIS_Summary of Results EN 22081
SUM-7058
 2023-11-02T11:42:09 Submitted Summary of Results

Layperson summary Annex V

TitleSubmission dateStatusType
22081_PLS_en_for publication 2023-11-02T11:45:04 Submitted Laypersons Summary of Results

Documents 6 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Clinical study report (for publication) Clinical_Study_Report_Document_Public_2022-500201-41-00_EN 1
Clinical study report (for publication) Documentation_of_Statistical_Methods_Public_2022-500201-41-00_EN 1
Clinical study report (for publication) Protocol_and_Protocol_Amendments_Public_2022-500201-41-00_EN 1
Clinical study report (for publication) Sample_Case_Report_Form_Public_2022-500201-41-00_EN 1
Laypersons summary of results (for publication) 22081_PLS_en_for publication 1
Summary of results (for publication) CTIS_Summary of Results EN 22081 1

Application history

3 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2022-04-14 Germany Acceptable
2022-07-25
 2022-07-28
2 NON SUBSTANTIAL MODIFICATION NSM-1 2022-09-02 Germany Acceptable
2022-07-25
 2022-09-02
3 NON SUBSTANTIAL MODIFICATION NSM-2 2022-10-19 Germany Acceptable
2022-07-25
 2022-10-19

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