ICON
Groningen, 9728 NZ, Netherlands
NCT Number: NCT06809608
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).
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Notify Me18 year–65 year
All sexes
Interventional
Phase 1
Groningen, 9728 NZ, Netherlands
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A single dose will be administered orally per study period (see arm descriptions).
Other names: CT-996, RG6652
Administered orally (see arm description).
Administered orally (see arm description).
A single dose will be administered orally per study period (see arm descriptions).
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
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
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
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Part 1, Period 2: Days -3 to 2, 4, 6, 8, and 14
Time frame: Part 2, Period 2: Days -1 to 2, and 4
Time frame: Part 2, Period 3: Days 1 to 5, and 7; Part 2, Period 4: Days 1 to 5, and 7
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Hoffmann-La Roche
Industry
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
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.
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