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Healthy ParticipantsPhase 1NCT06809608

A Study Investigating the Effect of Different Approved Medications on How the Body Processes the Study Compound RO7795081

A Phase 1 study testing RO7795081, Itraconazole and Gemfibrozil in people with Healthy Participants, run by Hoffmann-La Roche at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a single-center, non-randomized, open-label, cross-over study in healthy male and female participants. Part 1 of the study has a 2-period (a single fixed sequence) design and will investigate the impact of itraconazole on the pharmacokinetics (PK) of RO7795081 in healthy participants. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Participants
What is being tested?
RO7795081, Itraconazole and Gemfibrozil
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteNetherlands
Study dates
13 Feb 2025to 28 May 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Healthy biological males or females, defined by absence of evidence of any active or chronic disease
  • Ability to communicate with the Investigator
  • Able and willing to attend the necessary visits to the study site
  • Not under judicial supervision, guardianship, or curatorship
  • Body mass index (BMI) of 18 to 32 kg/m^2 inclusive, and a body weight of ≥50 kilograms at screening

Who cannot join

  • Any condition or disease detected during the medical interview/physical examination that would render the participant unsuitable for the study, place the participant at undue risk or interfere with the ability of the participant to complete the study in the opinion of the Investigator
  • History or presence of any clinically significant cardiovascular, bronchopulmonary, hepatic, renal, gastrointestinal, endocrinological, hematological, neurological, psychiatric, genitourinary, metabolic disorders, allergic diseases, cancer, or cirrhosis
  • History or evidence of any medical condition capable of significantly altering the absorption, metabolism, or elimination of drugs
  • Surgical history of the GI tract affecting gastric motility or altering the GI tract (with the exception of uncomplicated appendectomy and cholecystectomy)
  • History of malignancy in the past 5 years, except for fully treated local basal carcinoma, or fully treated carcinoma in situ of cervix
  • History of convulsions (other than benign febrile convulsions of childhood) including epilepsy, or personal history of significant cerebral trauma or central nervous system infections (e.g., meningitis)
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  • Any major illness (in the opinion of the Investigator) within 1 month before the screening examination or any febrile illness (in the opinion of the Investigator) within 1 week prior to screening and within 1 week prior to admission
  • History of clinically significant hypersensitivity (e.g., drugs [including but not limited to lidocaine, caffeine, povidone-iodine], excipients) or clinically significant allergic reactions
  • Have an abnormal blood pressure at the time of screening and on baseline, confirmed by the average of 3 blood pressure measurements, properly measured with well-maintained equipment: supine systolic blood pressure <90 millimetres of mercury (mmHg) or >140 mmHg or diastolic blood pressure <45 mmHg or >90 mmHg
  • Confirmed (based on the average of ≥ 3 consecutive measurements) resting pulse rate greater than 100 or less than 40 beats per minute at the time of screening and on baseline
  • History or presence during screening and baseline of clinically significant ECG abnormalities before study drug administration (e.g., PQ/PR interval >210 milliseconds (ms), QTcF >450 ms [>470 ms female participants], based on the average interval on triplicate ECGs) or cardiovascular disease (e.g., cardiac insufficiency, coronary artery disease, cardiomyopathy, congestive heart failure, family history of congenital long QT syndrome, family history of sudden death)
  • Clinically significant abnormalities in laboratory test results (including hepatic and renal panels, complete blood count, chemistry panel, and urinalysis). In the case of uncertain or questionable results, tests performed during screening may be repeated before randomization to confirm eligibility
  • Any suspicion or history of alcohol abuse and/or suspicion of regular consumption of drug of abuse (including cannabis-containing products) and/or evidence of current or previous drug of abuse (including cannabis-containing products) dependency within 5 years before screening
  • Participants who, in the Investigator's judgment, pose a suicidal or homicidal risk, or any participant with a history of suicidal or homicidal attempts
  • Bipolar disorder, schizophrenia or any other serious psychiatric condition (e.g., Axis I Disorder, DSM-IV-TR)
  • Uncontrolled behavioral symptoms incompatible with compliance or evaluability (e.g., severe agitation, lack of impulse control, violence, and severe dysphoria)
  • Any other medical condition not previously mentioned that could be expected to progress, recur, or change to such an extent that it could bias the assessment of the clinical or mental status of the participant to a significant degree or put the participant at special risk
  • Presence of any acute or chronic illness or history of chronic illness not otherwise mentioned elsewhere and sufficient to invalidate the participant's participation in the trial or make it unnecessarily hazardous. Such conditions may include clinically significantly impaired endocrine, thyroid, hepatic, respiratory or renal function for any reason, unstable diabetes mellitus and insulin-dependent diabetes mellitus, clinically significant cardiovascular disease, pheochromocytoma, or history of any psychotic mental illness
  • Known active or uncontrolled bacterial, viral, fungal, mycobacterial infection or other infection, excluding fungal infection of nail beds, including participants exhibiting symptoms consistent with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) within 6 weeks prior to Period 1 Day 1
  • Vaccination within 6 weeks prior to Period 1 Day 1, including influenza and/or SARS-CoV-2/COVID-19 vaccination
  • Use of any prohibited medications and food before study start and during the study
  • Participants likely to need concomitant medication during the study period, with some exceptions
  • Participation in an investigational drug or device study within 90 days prior to dosing, as calculated from the day of follow-up from the previous study or within 30 days
  • Participation in an investigational drug study involving any therapeutic monoclonal antibody, protein derived from a monoclonal antibody, immunoglobulin therapy, or vaccine (with the exception of approved SARS-CoV-2/ COVID-19 vaccination) within 6 months prior to dosing (unless it can be documented that the participant was randomized to placebo) as calculated from the day of last dosing from the previous study
  • Positive test for drugs of abuse or alcohol
  • Positive result on human immunodeficiency virus (HIV)1 and HIV2, hepatitis C virus, or hepatitis B surface antigen
  • Any suspicion or history of regular alcohol consumption for 1 month before screening defined as ≥21 drinks per week for males and ≥14 drinks per week for females
  • Smokers who smoke more than 5 cigarettes per day or equivalent amount of tobacco (including e-cigarettes/vapes) as determined by history, and unable or unwilling not to smoke during the in-clinic period
  • Donated over 450 mL of blood or blood products or had significant blood loss within 3 months prior to screening
  • Dietary restrictions that would prohibit the consumption of standardized meals
  • History of hypersensitivity to itraconazole (or any other triazole antifungal agent), gemfibrozil, cyclosporine, or their formulation ingredients
  • Inability or unwillingness to meet study requirements
  • Predictable poor compliance or inability to communicate well with the Investigator

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • ICON

    Groningen, 9728 NZ

Other trials in Netherlands

About this study

Official title: An Open-Label, Fixed Sequence Study to Investigate the Effect of Multiple Oral Doses of Itraconazole, Multiple Oral Doses of Gemfibrozil, and Single Oral Dose of Cyclosporine, on the Pharmacokinetics of a Single Oral Dose of RO7795081 in Healthy Participants

This is a single-center, non-randomized, open-label, cross-over study in healthy male and female participants.

Part 1 of the study has a 2-period (a single fixed sequence) design and will investigate the impact of itraconazole on the pharmacokinetics (PK) of RO7795081 in healthy participants. A maximum of up to 25 participants will be enrolled in Part 1 and sequentially undergo Period 1 (RO7795081 alone) followed by Period 2 (RO7795081 with itraconazole).

Part 2 of the study has an adaptive design with up to 4 periods (a single fixed sequence) and will investigate the impact of gemfibrozil and cyclosporine on the PK of RO7795081 in healthy participants. A maximum of up to 25 participants will be enrolled in Part 2 and sequentially undergo Period 1 (RO7795081 alone) followed by Period 2 (RO7795081 with gemfibrozil), Period 3 (RO7795081 with cyclosporine 200 mg), and finally Period 4 (RO7795081 with cyclosporine ≤600 mg).

Being tested
RO7795081, Itraconazole, Gemfibrozil, Cyclosporine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RO7795081Drug

    Also called CT-996, RG6652

    A single dose will be administered orally per study period (see arm descriptions).

  • ItraconazoleDrug

    Administered orally (see arm description).

  • GemfibrozilDrug

    Administered orally (see arm description).

  • CyclosporineDrug

    A single dose will be administered orally per study period (see arm descriptions).

Study groups in NCT06809608
Study groupRoleWhat they receive
Part 1: RO7795081, Then RO7795081 and ItraconazoleExperimentalIn Part 1, Period 1 (8 days), participants will be administered a single oral dose of RO7795081 on Day 1. Washout period between Period 1 Day 1 and Period 2 Day -3: at least 7 days. In Part 1, Period 2 (26 days), participants will receive a 3-day lead-in oral administration of itraconazole (200 mg twice daily [BID] on Day -3 and 200 mg once daily [QD] on Day -2 and Day -1). On Day 1, a single oral dose of RO7795081 will be co-administered with itraconazole (200 mg QD), followed by continued itraconazole dosing (200 mg QD) from Day 2 up to and including Day 9.
Receives: Drug: RO7795081; Drug: Itraconazole
Part 2: RO7795081, Then RO7795081 and Gemfibrozil, Then RO7795081 and CyclosporineExperimentalIn Part 2, Period 1 (8 days), participants will be administered a single oral dose of RO7795081 on Day 1. Washout period between Period 1 Day 1 and Period 2 Day -2: at least 7 days. In Part 2, Period 2 (10 days), participants will be co-administered a single oral dose of RO7795081 with gemfibrozil (600 mg BID) on Day 1, after a 2-day lead-in oral administration of gemfibrozil 600 mg BID (Day -2 to Day -1) followed by continued BID dosing up to and including Day 3. Washout period between Period 2 Day 1 and Period 3 Day 1: at least 7 days. In Part 2, Period 3 (8 days), participants will be co-administered a single oral dose of RO7795081 and a single oral dose of cyclosporine (200 mg) on Day 1. Washout period between Period 3 Day 1 and Period 4 Day 1: at least 7 additional days after Period 3 Day 7 (total of 14 days). In Part 2, Period 4 (18 days), participants will be co-administered a single oral dose of RO7795081 and a single oral dose of cyclosporine (600 mg or less) on Day 1.
Receives: Drug: RO7795081; Drug: Gemfibrozil; Drug: Cyclosporine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part 1: Maximum Concentration Observed (Cmax) of RO7795081, Administered Alone and in Combination with Itraconazole

    Measured: Part 1, Period 1: Days 1 to 5 and 7; Part 1, Period 2: Days -4, -1, 1 to 10, 12, 14, 20, and 26

  2. Part 1: Time to Maximum Concentration Observed (Tmax) of RO7795081, Administered Alone and in Combination with Itraconazole

    Measured: Part 1, Period 1: Days 1 to 5 and 7; Part 1, Period 2: Days -4, -1, 1 to 10, 12, 14, 20, and 26

  3. Part 1: Area Under the Concentration-Time Curve from Time 0 to the Last Measurable Concentration (AUClast) of RO7795081, Administered Alone and in Combination with Itraconazole

    Measured: Part 1, Period 1: Days 1 to 5 and 7; Part 1, Period 2: Days -4, -1, 1 to 10, 12, 14, 20, and 26

  4. Part 1: Area Under the Concentration-Time Curve from Time 0 to Infinity (AUCinf) of RO7795081, Administered Alone and in Combination with Itraconazole

    Measured: Part 1, Period 1: Days 1 to 5 and 7; Part 1, Period 2: Days -4, -1, 1 to 10, 12, 14, 20, and 26

  5. Part 2: Cmax of RO7795081, Administered Alone and in Combination with Gemfibrozil or Cyclosporine

    Measured: Part 2, Period 1: Days 1 to 5 and 7; Part 2, Period 2: Days -3 to 5, and 7; Part 2, Period 3: Days -1 to 5, and 7; Part 2, Period 4: Days -1 to 5, 7, and 18

  6. Part 2: Tmax of RO7795081, Administered Alone and in Combination with Gemfibrozil or Cyclosporine

    Measured: Part 2, Period 1: Days 1 to 5 and 7; Part 2, Period 2: Days -3 to 5, and 7; Part 2, Period 3: Days -1 to 5, and 7; Part 2, Period 4: Days -1 to 5, 7, and 18

  7. Part 2: AUClast of RO7795081, Administered Alone and in Combination with Gemfibrozil or Cyclosporine

    Measured: Part 2, Period 1: Days 1 to 5 and 7; Part 2, Period 2: Days -3 to 5, and 7; Part 2, Period 3: Days -1 to 5, and 7; Part 2, Period 4: Days -1 to 5, 7, and 18

  8. Part 2: AUCinf of RO7795081, Administered Alone and in Combination with Gemfibrozil or Cyclosporine

    Measured: Part 2, Period 1: Days 1 to 5 and 7; Part 2, Period 2: Days -3 to 5, and 7; Part 2, Period 3: Days -1 to 5, and 7; Part 2, Period 4: Days -1 to 5, 7, and 18

Secondary outcomes (7)

  1. Part 1: Plasma Concentrations of Itraconazole and Hydroxy-Itraconazole Over Time

    Measured: Part 1, Period 2: Days -3 to 2, 4, 6, 8, and 14

  2. Part 2: Plasma Concentrations of Gemfibrozil Over Time

    Measured: Part 2, Period 2: Days -1 to 2, and 4

  3. Part 2: Blood Concentrations of Cyclosporine Over Time

    Measured: Part 2, Period 3: Days 1 to 5, and 7; Part 2, Period 4: Days 1 to 5, and 7

  4. Incidence and Severity of Adverse Events

    Measured: Part 1: from first study treatment until safety follow-up visit (37 days); Part 2: from first study treatment until safety follow-up visit (56 days)

  5. Incidence of Abnormal Clinical Laboratory Test Findings

    Measured: Part 1: from first study treatment until safety follow-up visit (37 days); Part 2: from first study treatment until safety follow-up visit (56 days)

  6. Incidence of Abnormal Vital Signs

    Measured: Part 1: from first study treatment until safety follow-up visit (37 days); Part 2: from first study treatment until safety follow-up visit (56 days)

  7. Incidence of Electrocardiogram (ECG) Parameter Abnormalities

    Measured: Part 1: from first study treatment until safety follow-up visit (37 days); Part 2: from first study treatment until safety follow-up visit (56 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Feb 2025
  2. Study start13 Feb 2025
  3. Primary completion28 May 2025
  4. Study completion28 May 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Basic science
Allocation
Non-randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06809608
Sponsor's protocol ID
BP45670
Other IDs
2024-517360-37-00
Status last verified
Sep 2026
First submitted
30 Jan 2025
Last updated
28 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing RO7795081, Itraconazole and Gemfibrozil in people with Healthy Participants, run by Hoffmann-La Roche at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part 1: Maximum Concentration Observed (Cmax) of RO7795081, Administered Alone and in Combination with Itraconazole (time frame: Part 1, Period 1: Days 1 to 5 and 7; Part 1, Period 2: Days -4, -1, 1 to 10, 12, 14, 20, and 26). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06809608.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.

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