A study investigating the effect of several doses of itraconazole on how the body processes RO7269162, a new compound in clinical development for the treatment of Alzheimer’s disease
| ISRCTN | ISRCTN84512041 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN84512041 |
| EudraCT/CTIS number | 2024-510732-52-00 |
| Secondary identifying numbers | BP45228 |
- Submission date
- 15/05/2024
- Registration date
- 17/05/2024
- Last edited
- 16/05/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
Alzheimer’s disease is a form of dementia (memory loss). This study is testing a medicine called RO7269162. It is being developed to treat Alzheimer’s disease. RO7269162 is an experimental medicine. This means health authorities (like the U.S. Food and Drug Administration and European Medicines Agency) have not approved RO7269162 for the treatment of Alzheimer’s disease. This study aims to test how safe RO7269162 is. Also, it aims to understand what happens to RO7269162 once it is in the body and if there are any changes when it is taken with another medicine called itraconazole at the same time.
Who can participate?
Healthy participants (males and females) of 18 to 55 years of age and a body mass index (BMI) of 18 to 30 kilogram per meter squared (kg/m2) can take part in the study.
Participants may not be able to take part in this study if they smoke more than 5 cigarettes per day, need to follow certain dietary restrictions, or are likely to take medication during the study.
Participants who are pregnant, or currently breastfeeding cannot take part in the study.
What does the study involve?
Participating in the study will take up to 9 weeks from screening to follow-up. Participants will be screened to check if they can participate in the study. The screening period will take place from 28 days to 2 days before the start of treatment.
Everyone who joins this study will receive the study drug in 2 periods. Participants will be given RO7269162, as a pill by mouth, on Day 1 of Period 1 and Period 2. Participants will also be given itraconazole, as a pill by mouth starting 3 days before Day 1 of Period 2 up to Day 9 of Period 2.
During this study, the study doctor will see participants regularly during the in-house periods (overnight stays at the clinic) and ambulatory visits (short visits during a day at the clinic). The first in-house period lasts 6 days, followed by 1 ambulatory visit, then Period 2 starts, with 14 days in-house, followed by 2 ambulatory visits. Participants will then have a follow-up visit 2 to 6 days after completing the second study treatment period, during which the study doctor will check on the participant’s well-being.
Participants have the right to stop the study drug and leave the study at any time if they wish to do so.
This is an open-label study. This means everyone involved, including the participant and the study doctor, will know the study treatment the participant has been given.
What are the possible benefits and risks of participating?
Taking part in the study may or may not make participants feel better. However, the information collected in the study can help other people with similar health conditions in the future.
It may not be fully known at the time of the study how safe and how well the study treatment works. The study involves some risks to the participants. However, these risks are generally not greater than those related to routine medical care or the natural progression of the health condition. People interested in taking part will be informed about the risks and benefits, as well as any additional procedures or tests they may need to undergo. All details of the study will be described in an informed consent document. This includes information about possible effects and other options for treatment.
Risks associated with the study
Participants may have unwanted effects of the medicines used in this study. These unwanted effects can be mild to severe, even life-threatening, and vary from person to person. During this study, participants will have regular check-ups to see if there are any unwanted effects.
RO7269162
Participants will be told about the known unwanted effects of RO7269162 and possible unwanted effects based on human and laboratory studies or knowledge of similar medicines. Known unwanted effects include headache, changes to the skin, frequent watery stools (diarrhoea), vomiting, queasy feeling in the stomach that gives the sensation of wanting to vomit (nausea), the feeling of spinning, being unsteady and losing balance (dizziness), and back pain.
Itraconazole
Known unwanted effects include stomach ache, nausea, and headache.
The study medicine may be harmful to an unborn baby. Women and men must take precautions to avoid exposing an unborn baby to the study treatment.
Where is the study run from?
F. Hoffmann-La Roche Ltd (Switzerland)
When is the study starting and how long is it expected to run for?
April 2024 to September 2026
Who is funding the study?
F. Hoffmann-La Roche Ltd (Switzerland)
Who is the main contact?
global.trial_information@roche.com
Contact information
Public, Principal Investigator
Building 1, Grenzacherstrasse 124
Basel
CH-4070
Switzerland
| Phone | +41 616878333 |
|---|---|
| global.trial_information@roche.com |
Scientific
Building 1, Grenzacherstrasse 124
Basel
CH-4070
Switzerland
| Phone | +41 616878333 |
|---|---|
| global.trial_information@roche.com |
Study information
| Study design | Phase I single-center non-randomized open-label single-sequence two-period drug-drug interaction study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Pharmaceutical testing facility |
| Study type | Other |
| Participant information sheet | No participant information sheet available |
| Scientific title | A single-center, open-label, two-period study to investigate the effect of multiple-dose itraconazole, a strong CYP3A inhibitor, on the pharmacokinetics of a single dose of RO7269162 in healthy participants |
| Study objectives | The main purpose of this study is to assess the effect of multiple doses of itraconazole on the single-dose pharmacokinetics (PK) of RO7269162 in healthy participants. |
| Ethics approval(s) |
Approved 01/05/2024, Stichting Beoordeling Ethiek Biomedisch Onderzoek (Weiersstraat 1C, Assen, 9401 ET, Netherlands; +31 0592 40 58 71; info@stbebo.nl), ref: Nil known |
| Health condition(s) or problem(s) studied | Healthy volunteer |
| Intervention | Participants will receive a single dose of RO7269162, orally on Day 1 of Period 1. After an interval of at least 7 days, participants will receive itraconazole, orally, once daily, from Day -3 to Day 9 of Period 2. Participants will also receive a single dose of RO7269162, orally on Day 1 of Period 2. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | Pharmacokinetic, Drug:drug interaction |
| Phase | Phase I |
| Drug / device / biological / vaccine name(s) | RO7269162, Itraconazole |
| Primary outcome measure | 1. Maximum observed plasma concentration (Cmax) of RO7269162 determined using blood samples collected at pre-dose and multiple time-points post-dose from Day 1 up to Day 7 of Period 1 and Day 1 up to Day 14 of Period 2 2. Time to maximum plasma concentration (Tmax) of RO7269162 determined using blood samples collected at pre-dose and multiple time-points post-dose from Day 1 up to Day 7 of Period 1 and Day 1 up to Day 14 of Period 2 3. Area under the plasma concentration-time curve from time zero up to the last measurable concentration (AUClast) of RO7269162 determined using blood samples collected at pre-dose and multiple time-points post-dose from Day 1 up to Day 7 of Period 1 and Day 1 up to Day 14 of Period 2 4 Area under the plasma concentration-time curve from time zero extrapolated to infinity (AUCinf) of RO7269162 determined using blood samples collected at pre-dose and multiple time-points post-dose from Day 1 up to Day 7 of Period 1 and Day 1 up to Day 14 of Period 2 |
| Secondary outcome measures | 1. Number of participants with adverse events (AEs) and severity of AEs determined according data captured on the electronic case report forms (eCRF) from Screening to Follow-up (up to approximately 9 weeks) 2. Plasma Concentration of itraconazole determined using blood samples collected at pre-dose and multiple time-points post-dose from Day -3 to Day 14 of Period 2 |
| Overall study start date | 04/03/2024 |
| Completion date | 23/07/2024 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 55 Years |
| Sex | Both |
| Target number of participants | 18 |
| Key inclusion criteria | 1. Body mass index (BMI) of 18 to 30 kilograms per metre squared (kg/m2) inclusive (at screening) 2. Participants who are overtly healthy determined by no clinically significant findings from medical history, 12-lead electrocardiogram (ECG), or vital signs |
| Key exclusion criteria | 1. History or presence of any clinically significant cardiovascular, bronchopulmonary, hepatic, renal, gastrointestinal, endocrinological, hematological, neurological, psychiatric, genitourinary, metabolic disorders, allergic diseases, cancer, or cirrhosis 2. History or evidence of any medical condition capable of significantly altering the absorption, metabolism, or elimination of drugs 3. Surgical history of the gastrointestinal tract affecting gastric motility or altering the gastrointestinal tract 4. History of malignancy in the past 5 years 5. Known active or uncontrolled bacterial, viral, fungal, mycobacterial infection, or other Infection 6. Participation in an investigational drug study involving any therapeutic monoclonal antibody 7. Positive test for drugs of abuse or alcohol 8. Positive result on human immunodeficiency virus (HIV) 1 and HIV2, hepatitis C virus (HCV) or hepatitis B virus (HBV) 9. Participants who have donated over 500 milliliters (mL) of blood or blood products or had significant blood loss within 3 months before screening. |
| Date of first enrolment | 07/06/2024 |
| Date of final enrolment | 28/06/2024 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Groningen
9728 NZ
Netherlands
Sponsor information
Industry
Building 1, Grenzacherstrasse 124
Basel
CH-4070
Switzerland
| Phone | 41 616878333 |
|---|---|
| global.trial_information@roche.com | |
| Website | https://www.roche.com/about |
Funders
Funder type
Industry
Private sector organisation / For-profit companies (industry)
- Alternative name(s)
- Hoffman-La Roche, F. Hoffmann-La Roche Ltd.
- Location
- Switzerland
Results and Publications
| Intention to publish date | 23/07/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available due to participant-level data not being a regulatory requirement. |
Editorial Notes
16/05/2024: Study's existence confirmed by the Ethics Assessment Foundation Biomedical Research Medical Ethical Review Committee (METC Assen).
