Phase 1
Completed N=18
A Study to Investigate the Effect of RO7049389 on the Pharmacokinetics of Pitavastatin in Healthy Volunteers
Healthy Volunteers
Source: ClinicalTrials.gov NCT03717064 ↗
Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Jan 2020
Primary outcomePrimary: Period 1: Maximum Plasma Concentration (Cmax) of Pitavastatin — 23.8 ng/mL
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Period 1: Maximum Plasma Concentration (Cmax) of Pitavastatin |
23.8 | — |
| PRIMARY Period 1: Plasma Concentration Versus Time (Area Under the Curve, AUC0-inf) of Pitavastatin |
78.6 | — |
| PRIMARY Period 1: Time to Maximum Concentration (Tmax) of Pitavastatin |
1.5 | — |
| PRIMARY Period 1: Apparent Total Clearance (CL/F) of Pitavastatin |
25.4 | — |
| PRIMARY Period 1: Volume of Distribution (V/F) of Pitavastatin |
525 | — |
| PRIMARY Period 1: Elimination Half-Life (T1/2) of Pitavastatin |
14.3 | — |
| PRIMARY Period 2: Maximum Plasma Concentration (Cmax) of Pitavastatin |
33.5 | — |
| PRIMARY Period 2: Plasma Concentration Versus Time (Area Under the Curve, AUC0-inf) of Pitavastatin |
129 | — |
| PRIMARY Period 2: Time to Maximum Concentration (Tmax) of Pitavastatin |
2 | — |
| PRIMARY Period 2: Apparent Total Clearance (CL/F) of Pitavastatin |
15.6 | — |
| PRIMARY Period 2: Volume of Distribution (V/F) of Pitavastatin |
220 | — |
| PRIMARY Period 2: Elimination Half-Life (T1/2) of Pitavastatin |
9.78 | — |
| SECONDARY Percentage of Participants With Adverse Events (AEs) |
39 | — |
| SECONDARY Period 2: Cmax of RO7049389 |
15400; 17600 | — |
| SECONDARY Period 2: AUC-tau of RO7049389 |
62700; 68500 | — |
| SECONDARY Period 1: Cmax of Pitavastatin Lactone |
14.4 | — |
| SECONDARY Period 1: AUC0-inf of Pitavastatin Lactone |
193 | — |
| SECONDARY Period 1: AUC Ratio of Pitavastatin Lactone to Pitavastatin |
2.45 | — |
| SECONDARY Period 2: Cmax of Pitavastatin Lactone |
6.39 | — |
| SECONDARY Period 2: AUC0-inf of Pitavastatin Lactone |
81.7 | — |
| SECONDARY Period 2: AUC Ratio of Pitavastatin Lactone to Pitavastatin |
0.636 | — |
Eligibility Criteria
Inclusion Criteria
- Healthy, as judged by the Investigator. Healthy status is defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead ECG, and based on the laboratory safety test results at screening and Day -1
- Body mass index (BMI) between 18 to 30 kg/m2 (inclusive) at screening
- Female participants: 1) Must be either surgically sterile (by means of hysterectomy and/or bilateral oophorectomy and/or bilateral salpingectomy) or post-menopausal for at least one year (defined as amenorrhea >/=12 consecutive months without another cause, and confirmed by follicle-stimulating hormone (FSH) level. 2) Participants must not be pregnant or lactating.
- Male participants: 1) Female partners must not be pregnant or lactating. 2) Must agree to remain abstinent (refrain from heterosexual intercourse) or must agree to use a condom with spermicide during the treatment period and for at least 28 days after the last dose of study drug with female partners of childbearing potential. 3) Must agree to refrain from donating sperm during the treatment period and for at least 28 days after the last dose of study drug
Exclusion Criteria
- Have a history or symptoms of any clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, oncologic or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study treatment; or of interfering with the interpretation of data
- Confirmed (based on the average of 3 separate resting BP measurements in a supine position, after at least 5 minutes rest) systolic BP greater than 140 or less than 90 mmHg, and diastolic BP greater than 90 or less than 50 mmHg at screening and Day -1
- Personal history or family history of congenital long QT syndrome and/or cardiac sudden death
- History of Gilbert's syndrome
- Participants who have had significant acute infection, e.g., influenza, local infection, acute gastrointestinal symptoms or any other clinically significant illness within two weeks of dose administration
- Any confirmed significant allergic reactions (urticaria or anaphylaxis) against any drug, or multiple drug allergies (non-active hay fever is acceptable)
- Taking any herbal medications or substances (e.g., tea) or supplements (including vitamins), or traditional Chinese medicines (TCM) or over-the-counter (OTC) medications within 14 days of first dosing or within 5 times the elimination half-life of the medication prior to first dosing, whichever is longer
- History of having received any systemic anti-neoplastic (including radiation) or immunemodulatory treatment (including systemic oral or inhaled corticosteroids) 5 cigarettes or equivalent nicotine-containing product per day prior to screening
Data sourced from ClinicalTrials.gov (NCT03717064). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.