Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
16
Countries
1
Sites
1
Vasomotor symptoms as a sex hormone-dependent disorder in women and men
To investigate the relative bioavailability of two soft gel capsule formulations versus the currently used Phase 3 formulation when administered as single oral dose under fasting conditions
Key facts
- Sponsor
- Bayer Consumer Care AG, Bayer AG
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Hormonal diseases [C19]
- Trial duration
- 25 Sep 2023 → 27 Nov 2023
- Decision date (initial)
- 2023-07-14
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Others
To investigate the relative bioavailability of two soft gel capsule formulations versus the currently used Phase 3 formulation when administered as single oral dose under fasting conditions
Secondary objectives 1
- To investigate the safety and tolerability of elinzanetant
Conditions and MedDRA coding
Vasomotor symptoms as a sex hormone-dependent disorder in women and men
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | LLT | 10067819 | Andropausal symptoms | 10014698 |
| 21.0 | LLT | 10020407 | Hot flashes | 10047065 |
| 21.1 | PT | 10027304 | Menopausal symptoms | 100000004872 |
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Overall Study This study will be conducted in a single study center according to an open-label, randomized crossover design in healthy male and female participants aged 18 to 55 years.
The participants will be randomized to one of 2 sequences (A-B-C, B-A-C).
The participants will receive the following study interventions:
• Treatment A:2 x 60 mg , Phase 3 formulation
• Treatment B: 2 x 60 mg , Formulation 3
• Treatment C: 2 x 60 mg , Formulation 1
|
Randomised Controlled | None | Treatment sequence: A-B-C: The participants in this arm will receive the following study interventions in treatment sequence A, B and C. The investigational medicinal products will be administered as single oral doses on Day 1 of each period. A period last 7 days and a washout of at least 7 days will be between each administration. • Treatment A:2 x 60 mg , Phase 3 formulation • Treatment B: 2 x 60 mg , Formulation 3 • Treatment C: 2 x 60 mg , Formulation 1 Treatment sequence: B-A-C: The participants in this arm will receive the following study interventions in treatment sequence B, A and C. The investigational medicinal products will be administered as single oral doses on Day 1 of each period. A period last 7 days and a washout of at least 7 days will be between each administration. • Treatment A:2 x 60 mg , Phase 3 formulation • Treatment B: 2 x 60 mg , Formulation 3 • Treatment C: 2 x 60 mg , Formulation 1 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 2
- Participant must be 18 to 55 years of age inclusive, at the time of signing the informed consent.
- Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, blood pressure, pulse rate, body temperature, 12-lead ECG, and laboratory tests.
Exclusion criteria 4
- Pregnant or breastfeeding women.
- Medical disorder, condition, or history of such that would impair the participant’s ability to take part in or complete this study in the opinion of the investigator. This includes family history indicating hereditary predisposition of relevant diseases and history of non- persisting diseases with possible impact on study participation.
- Diseases for which it can be assumed that the absorption, distribution, metabolism, elimination, and effects of the study intervention(s) will not be normal.
- Regular use of prescription drugs, over-the-counter drugs, supplements (e.g., carnitine products, anabolics, high dose vitamins) or herbal products.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- Area under the concentration vs. time curve from zero to infinity after single (first) dose (AUC)* after single dose under fasted condition *Area under the concentration vs. time curve from zero to last quantifiable concentration (AUC(0-tlast)) will be used as main parameter if AUC cannot be calculated reliably in all participants
- Maximum observed concentration (Cmax) after single dose under fasted condition
Secondary endpoints 1
- Number of participants with treatment-emergent adverse events and severity of treatment-emergent adverse events
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 3
PRD10355798 · 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
PRD10355797 · 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
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
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Bayer Consumer Care AG
- Sponsor organisation
- Bayer Consumer Care AG
- Address
- Peter Merian-Strasse 84
- City
- Basel
- Postcode
- 4052
- Country
- Switzerland
Scientific contact point
- Organisation
- Bayer AG
- Contact name
- Therapeutic Area Head
Public contact point
- Organisation
- Bayer AG
- Contact name
- Therapeutic Area Head
Third parties 4
| Organisation | City, country | Duties |
|---|---|---|
| CRS Clinical Research Services Management GmbH ORG-100039537
|
Wuppertal, Germany | Code 5 |
| Swiss Bioquant AG ORG-100037230
|
Reinach Bl, Switzerland | Laboratory analysis |
| Labcorp Early Development Laboratories Inc. ORG-100012865
|
Greenfield, United States | Laboratory analysis |
| Mlm Medical Labs GmbH ORG-100043721
|
Mönchengladbach, Germany | Laboratory analysis |
Bayer AG
- Sponsor organisation
- Bayer AG
- Address
- Kaiser-Wilhelm-Allee 1, Wiesdorf Wiesdorf
- City
- Leverkusen
- Postcode
- 51373
- 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
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ended | 16 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Germany | 2023-09-25 | 2023-11-27 | 2023-10-04 | 2023-10-09 |
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
| Title | Submission date | Status | Type |
|---|---|---|---|
| Summary of Results_EN_2023-503968-16-00_public SUM-50829
|
2024-10-10T13:56:19 | Submitted | Summary of Results |
Layperson summary Annex V
| Title | Submission date | Status | Type |
|---|---|---|---|
| Layperson summary of results_EN_2023-503968-16-00_Public | 2024-10-10T13:57:15 | Submitted | Laypersons Summary of Results |
Documents 2 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Laypersons summary of results (for publication) | Layperson Summary of Results_EN_2023-503968-16-00_public | 1 |
| Summary of results (for publication) | Summary of Results_EN_2023-503968-16-00_public | 1 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-05-24 | Germany | Acceptable 2023-06-22
|
2023-07-14 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2023-10-06 | Germany | Acceptable 2023-06-22
|
2023-10-06 |