A Phase 1 interventional study of RO7049389 and Pitavastatin in Healthy Volunteers, sponsored by Hoffmann-La Roche. Completed at 1 site in United States. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-01-10.
Sponsored by Hoffmann-La Roche · Phase 1, Interventional, and Treatment
The main purpose of the study is to characterize the interaction between RO7049389 and the cholesterol-lowering drug, pitavastatin, in healthy volunteers. There is no intended clinical benefit to this study. The total duration of the study for each participant is approximately 12 weeks.
Hoffmann-La Roche is the lead sponsor of 2,099 studies on the registry; 88 are open to participants now.
Of its 324 completed or terminated interventional studies of FDA-regulated products, 245 (76%) have results posted.
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Exclusion Criteria
Period 1: Participants will receive a single dose of pitavastatin on Day 1, followed by a wash-out period of at least 7 and up to 21 days. Period 2: Participants will receive RO7049389 on Days 1-6. Participants will also receive a single dose of pitavastatin on Day 4.
Drug: RO7049389 · Drug: Pitavastatin
RO7049389 will be taken orally, in tablet form, BID on Days 1-6 of Period 2.
Pitavastatin will be taken orally, in tablet form, once on Day 1 of Period 1, and once on Day 4 of Period 2.
Period 1: Maximum Plasma Concentration (Cmax) of Pitavastatin
Time frame: Period 1 Day 1
Period 1: Plasma Concentration Versus Time (Area Under the Curve, AUC0-inf) of Pitavastatin
Time frame: Period 1 Day 1
Period 1: Time to Maximum Concentration (Tmax) of Pitavastatin
Time frame: Period 1 Day 1
Period 1: Apparent Total Clearance (CL/F) of Pitavastatin
Time frame: Period 1
Period 1: Volume of Distribution (V/F) of Pitavastatin
Time frame: Period 1 Day 1
Period 1: Elimination Half-Life (T1/2) of Pitavastatin
Time frame: Period 1 Day 1
Period 2: Maximum Plasma Concentration (Cmax) of Pitavastatin
Time frame: Period 2 Day 4
Period 2: Plasma Concentration Versus Time (Area Under the Curve, AUC0-inf) of Pitavastatin
Time frame: Period 2 Day 4
Period 2: Time to Maximum Concentration (Tmax) of Pitavastatin
Time frame: Period 2 Day 4
Period 2: Apparent Total Clearance (CL/F) of Pitavastatin
Time frame: Period 2 Day 4
Period 2: Volume of Distribution (V/F) of Pitavastatin
Time frame: Period 2 Day 4
Period 2: Elimination Half-Life (T1/2) of Pitavastatin
Time frame: Period 2 Day 4
Percentage of Participants With Adverse Events (AEs)
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
Time frame: From the start of Period 1 through safety follow-up (Period 2, Day 34)
Period 2: Cmax of RO7049389
Time frame: Period 2 Days 3-4
Period 2: AUC-tau of RO7049389
Time frame: Period 2 Days 3-4
Period 1: Cmax of Pitavastatin Lactone
Time frame: Period 1 Day 1
Period 1: AUC0-inf of Pitavastatin Lactone
Time frame: Period 1 Day 1
Period 1: AUC Ratio of Pitavastatin Lactone to Pitavastatin
Time frame: Period 1 Day 1
Period 2: Cmax of Pitavastatin Lactone
Time frame: Period 2 Day 4
Period 2: AUC0-inf of Pitavastatin Lactone
Time frame: Period 2 Day 4
Period 2: AUC Ratio of Pitavastatin Lactone to Pitavastatin
Time frame: Period 2 Day 4
This study recruited healthy adult participants at one site in the United States.
| Milestone | Pitavastatin/RO7049389 |
|---|---|
| Started | 18 |
| Completed | 18 |
| Not completed | 0 |
| Milestone | Pitavastatin/RO7049389 |
|---|---|
| Started | 18 |
| Completed | 17 |
| Not completed | 1 |
| Withdrew: Adverse event | 1 |
| ng/mL | Pitavastatin/RO7049389 |
|---|---|
| Period 1: Maximum Plasma Concentration (Cmax) of Pitavastatin | 23.8 ± 42.7 |
| h*ng/mL | Pitavastatin/RO7049389 |
|---|---|
| Period 1: Plasma Concentration Versus Time (Area Under the Curve, AUC0-inf) of Pitavastatin | 78.6 ± 41 |
| hours (h) | Pitavastatin/RO7049389 |
|---|---|
| Period 1: Time to Maximum Concentration (Tmax) of Pitavastatin | 1.5 (0.5 to 2) |
| L/h | Pitavastatin/RO7049389 |
|---|---|
| Period 1: Apparent Total Clearance (CL/F) of Pitavastatin | 25.4 ± 39.9 |
| Liters (L) | Pitavastatin/RO7049389 |
|---|---|
| Period 1: Volume of Distribution (V/F) of Pitavastatin | 525 ± 41.3 |
| h | Pitavastatin/RO7049389 |
|---|---|
| Period 1: Elimination Half-Life (T1/2) of Pitavastatin | 14.3 ± 32.4 |
| ng/mL | Pitavastatin/RO7049389 |
|---|---|
| Period 2: Maximum Plasma Concentration (Cmax) of Pitavastatin | 33.5 ± 52.7 |
| h*ng/mL | Pitavastatin/RO7049389 |
|---|---|
| Period 2: Plasma Concentration Versus Time (Area Under the Curve, AUC0-inf) of Pitavastatin | 129 ± 50.7 |
| h | Pitavastatin/RO7049389 |
|---|---|
| Period 2: Time to Maximum Concentration (Tmax) of Pitavastatin | 2 (0.5 to 4) |
| L/h | Pitavastatin/RO7049389 |
|---|---|
| Period 2: Apparent Total Clearance (CL/F) of Pitavastatin | 15.6 ± 45 |
| L | Pitavastatin/RO7049389 |
|---|---|
| Period 2: Volume of Distribution (V/F) of Pitavastatin | 220 ± 59.3 |
| h | Pitavastatin/RO7049389 |
|---|---|
| Period 2: Elimination Half-Life (T1/2) of Pitavastatin | 9.78 ± 49 |
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
| Percentage of Participants | Pitavastatin/RO7049389 |
|---|---|
| Percentage of Participants With Adverse Events (AEs) | 39 |
| ng/mL | Pitavastatin/RO7049389 |
|---|---|
| RO7049389 | 15400 ± 58.1 |
| RO7049389 + Pitavastatin | 17600 ± 48.4 |
| h*ng/mL | Pitavastatin/RO7049389 |
|---|---|
| RO7049389 | 62700 ± 92.8 |
| RO7049389 + Pitavastatin | 68500 ± 81.8 |
| ng/mL | Pitavastatin/RO7049389 |
|---|---|
| Period 1: Cmax of Pitavastatin Lactone | 14.4 ± 23.5 |
| h*ng/mL | Pitavastatin/RO7049389 |
|---|---|
| Period 1: AUC0-inf of Pitavastatin Lactone | 193 ± 27.4 |
| Ratio | Pitavastatin/RO7049389 |
|---|---|
| Period 1: AUC Ratio of Pitavastatin Lactone to Pitavastatin | 2.45 (2.17 to 2.78) |
| ng/mL | Pitavastatin/RO7049389 |
|---|---|
| Period 2: Cmax of Pitavastatin Lactone | 6.39 ± 24.4 |
| h*ng/mL | Pitavastatin/RO7049389 |
|---|---|
| Period 2: AUC0-inf of Pitavastatin Lactone | 81.7 ± 19.9 |
| Ratio | Pitavastatin/RO7049389 |
|---|---|
| Period 2: AUC Ratio of Pitavastatin Lactone to Pitavastatin | 0.636 (0.504 to 0.802) |
Collected over From the start of Period 1 through safety follow-up (Period 2, Day 34). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pitavastatin/RO7049389 | 0/18 (0%) | 0/18 (0%) | 7/18 (38.9%) |
| Event | Pitavastatin/RO7049389 |
|---|---|
| HeadacheNervous system disorders | 3/18 |
| NauseaGastrointestinal disorders | 2/18 |
| DizzinessNervous system disorders | 2/18 |
| Hypoaesthesia oralGastrointestinal disorders | 1/18 |
| VomitingGastrointestinal disorders | 1/18 |
| FatigueGeneral disorders | 1/18 |
| Musculoskeletal painMusculoskeletal and connective tissue disorders | 1/18 |
| RhinorrhoeaRespiratory, thoracic and mediastinal disorders | 1/18 |
| Age, Continuous(Years) | Pitavastatin/RO7049389 |
|---|---|
| Mean | 39.2 ± 14.5 |
| Sex: Female, Male(Participants) | Pitavastatin/RO7049389 |
|---|---|
| Female | 7 |
| Male | 11 |
| Ethnicity (NIH/OMB)(Participants) | Pitavastatin/RO7049389 |
|---|---|
| Hispanic or Latino | 8 |
| Not Hispanic or Latino | 10 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Pitavastatin/RO7049389 |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 5 |
| White | 13 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
Documents are hosted by the registry — open the source record to download them.
Ran from Nov 2018 to primary completion in Dec 2018, 1 month.
Results were first posted in Jan 2020, 1 year after primary completion.
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