ICON Plc (LPRA) - Netherlands
Groningen, 9728 NZ, Netherlands
Location status: Recruiting
NCT Number: NCT06982131
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.
Interested in participating?
Request Info18 year–65 year
All sexes
Interventional
Phase 1
Groningen, 9728 NZ, Netherlands
Location status: Recruiting
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
RO7795081 will be administered orally during Periods 3, 4, and 5, according to the protocol.
Other names: CT-996, RG6652
Placebo will be administered orally during Periods 3, 4, and 5, according to the protocol.
A single 10 mg dose of rosuvastatin (ROS) will be taken on Day 1 of Period 1 and on Day 1 of Period 4.
Other names: Crestor®
A single 1 mg dose of pitavastatin (PIT) will be taken on Day 1 of Period 2 and on Day 1 of Period 5.
Other names: Livazo®, Livalo®, Zypitamag®
Time frame: From the first dose of study treatment until the final visit (up to 111 days)
Time frame: From the first dose of study treatment until the final visit (up to 111 days)
Time frame: From the first dose of study treatment until the final visit (up to 111 days)
Time frame: From the first dose of study treatment until the final visit (up to 111 days)
Time frame: Periods 1 and 4: predose and postdose at prespecified times on Days 1 to 5
Time frame: Periods 1 and 4: predose and postdose at prespecified times on Days 1 to 5
Time frame: Periods 1 and 4: predose and postdose at prespecified times on Days 1 to 5
Time frame: Periods 1 and 4: predose and postdose at prespecified times on Days 1 to 5
Time frame: Periods 2 and 5: predose and postdose at prespecified times on Days 1 to 4
Time frame: Periods 2 and 5: predose and postdose at prespecified times on Days 1 to 4
Time frame: Periods 2 and 5: predose and postdose at prespecified times on Days 1 to 4
Time frame: Periods 2 and 5: predose and postdose at prespecified times on Days 1 to 4
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Contact information is provided by the study sponsor or research team.
Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
CONTACT
Reference Study ID Number: BP45800 https://forpatients.roche.com/ No attachments to email below.
CONTACT
888-662-6728 (U.S. Only)
Hoffmann-La Roche
Industry
A Phase I, Randomized, Investigator/Participant-Blind, Placebo-Controlled, Fixed-Sequence Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Multiple Doses of Orally Administered RO7795081 and the Effect of Steady-State Dose of Orally Administered RO7795081 on the Pharmacokinetics of Pitavastatin and Rosuvastatin in Otherwise Healthy Overweight or Obese Adult Participants
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07407348
Body Weight, Healthy
Nottingham, United Kingdom
View Trial DetailsNCT07497880
Body Weight, Diabetes Mellitus
Chandler, Arizona, United States
View Trial DetailsNCT07732426
Body Weight, Food Addiction Tendency
Seoul, South Korea
View Trial DetailsNCT07037433
Arterial Occlusive Diseases, Arteriosclerosis
Daphne, Alabama, United States
View Trial Details