Overweight, Obesity
Conditions
Brief summary
This is a randomized, investigator-and-participant-blind, placebo-controlled, fixed sequence, cross-over, Phase 1 study to investigate the safety, tolerability, and pharmacokinetics of multiple doses of orally administered RO7795081 and the effect of a steady-state dose of orally administered RO7795081 on the pharmacokinetics of pitavastatin and rosuvastatin in otherwise healthy, overweight or obese adult participants.
Interventions
DRUGRO7795081
RO7795081 will be administered orally during Periods 3, 4, and 5, according to the protocol.
DRUGPlacebo
Placebo will be administered orally during Periods 3, 4, and 5, according to the protocol.
DRUGRosuvastatin
A single 10 mg dose of rosuvastatin (ROS) will be taken on Day 1 of Period 1 and on Day 1 of Period 4.
DRUGPitavastatin
A single 1 mg dose of pitavastatin (PIT) will be taken on Day 1 of Period 2 and on Day 1 of Period 5.
Sponsors
Hoffmann-La Roche
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy participants with no clinically relevant findings on physical examination at screening and at baseline (including detailed medical and surgical history, vital signs, 12-lead ECG, hematology, blood chemistry, and urinalysis); with no suspicion of cognitive impairment or dementia as judged by the Investigator; who are not under judicial supervision, guardianship, or curatorship. * Body Mass Index (BMI) ≥27.0 kg/m\^2 at screening and on Day -1 of Period 1 * Stable body weight (defined as \<5% gain or loss) in the 2 months prior to screening as per verbal report by the participant and for the period between screening and Day -1 of Period 1 as per measured weight * Agreement to adhere to the contraception requirements
Exclusion criteria
* Pregnant, breastfeeding, or intending to become pregnant during the study * Any condition or disease detected during the medical interview or 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, broncho-pulmonary, hepatic, renal, gastrointestinal, endocrinological, hematological, neurological, psychiatric, or metabolic disorders, allergic diseases, hypofertility, cancer, or cirrhosis * History or evidence of any medical condition capable of significantly altering the absorption, metabolism, or elimination of drugs * History of convulsions (other than benign febrile convulsions of childhood) including epilepsy, or personal history of significant cerebral trauma or CNS infections (e.g., meningitis) * History of acute or chronic metabolic acidosis, including diabetic ketoacidosis with or without coma
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax of Pitavastatin, Administered Alone and in Combination with RO7795081 | Periods 2 and 5: predose and postdose at prespecified times on Days 1 to 4 |
| AUC from Time 0 to Infinity (AUCinf) of Rosuvastatin, Administered Alone and in Combination with RO7795081 | Periods 1 and 4: predose and postdose at prespecified times on Days 1 to 5 |
| Area Under the Plasma Concentration-Time Curve (AUC) from Time 0 to the Last Measurable Concentration (AUClast) of Rosuvastatin, Administered Alone and in Combination with RO7795081 | Periods 1 and 4: predose and postdose at prespecified times on Days 1 to 5 |
| Incidence and Severity of Adverse Events | From the first dose of study treatment until the final visit (up to 111 days) |
| Incidence of Abnormal Clinical Laboratory Test Results | From the first dose of study treatment until the final visit (up to 111 days) |
| Incidence of Abnormal Vital Sign Assessments | From the first dose of study treatment until the final visit (up to 111 days) |
| Incidence of Abnormal Electrocardiogram Parameters | From the first dose of study treatment until the final visit (up to 111 days) |
| Maximum Plasma Concentration Observed (Cmax) of Rosuvastatin, Administered Alone and in Combination with RO7795081 | Periods 1 and 4: predose and postdose at prespecified times on Days 1 to 5 |
| Time to Maximum Plasma Concentration (Tmax) of Rosuvastatin, Administered Alone and in Combination with RO7795081 | Periods 1 and 4: predose and postdose at prespecified times on Days 1 to 5 |
| Tmax of Pitavastatin, Administered Alone and in Combination with RO7795081 | Periods 2 and 5: predose and postdose at prespecified times on Days 1 to 4 |
| AUClast of Pitavastatin, Administered Alone and in Combination with RO7795081 | Periods 2 and 5: predose and postdose at prespecified times on Days 1 to 4 |
| AUCinf of Pitavastatin, Administered Alone and in Combination with RO7795081 | Periods 2 and 5: predose and postdose at prespecified times on Days 1 to 4 |
Secondary
| Measure | Time frame |
|---|---|
| Plasma Concentration of RO7795081 Over Time, Administered Alone and in Combination with Rosuvastatin and Pitavastatin | Period 3: predose and postdose at prespecified times from Days 2 to 49; Period 4: predose and postdose at prespecified times on Days 1 to 4; Periods 4: predose and postdose at prespecified times on Days 1 to 9 |
| Cmax of RO7795081, Administered Alone and in Combination with Rosuvastatin and Pitavastatin | Period 3: predose and postdose at prespecified times from Days 2 to 49; Period 4: predose and postdose at prespecified times on Days 1 to 4; Periods 4: predose and postdose at prespecified times on Days 1 to 9 |
| Tmax of RO7795081, Administered Alone and in Combination with Rosuvastatin and Pitavastatin | Period 3: predose and postdose at prespecified times from Days 2 to 49; Period 4: predose and postdose at prespecified times on Days 1 to 4; Periods 4: predose and postdose at prespecified times on Days 1 to 9 |
| AUClast of RO7795081, Administered Alone and in Combination with Rosuvastatin and Pitavastatin | Period 3: predose and postdose at prespecified times from Days 2 to 49; Period 4: predose and postdose at prespecified times on Days 1 to 4; Periods 4: predose and postdose at prespecified times on Days 1 to 9 |
| AUCinf of RO7795081, Administered Alone and in Combination with Rosuvastatin and Pitavastatin | Period 3: predose and postdose at prespecified times from Days 2 to 49; Period 4: predose and postdose at prespecified times on Days 1 to 4; Periods 4: predose and postdose at prespecified times on Days 1 to 9 |
Countries
Netherlands
Contacts
CONTACTReference Study ID Number: BP45800 https://forpatients.roche.com/
STUDY_DIRECTORClinical Trials
Hoffmann-La Roche
Outcome results
None listed