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A Study to Investigate the Effect of RO7049389 on the Pharmacokinetics of Pitavastatin in Healthy Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03717064
Recruitment Status : Completed
First Posted : October 24, 2018
Results First Posted : January 10, 2020
Last Update Posted : January 10, 2020
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief 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.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: RO7049389 Drug: Pitavastatin Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Fixed Sequence, Two-Period Study to Investigate the Effect of RO7049389 on the Pharmacokinetics of Pitavastatin in Healthy Volunteers
Actual Study Start Date : November 7, 2018
Actual Primary Completion Date : December 17, 2018
Actual Study Completion Date : December 17, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Pitavastatin

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
RO7049389 will be taken orally, in tablet form, BID on Days 1-6 of Period 2.

Drug: Pitavastatin
Pitavastatin will be taken orally, in tablet form, once on Day 1 of Period 1, and once on Day 4 of Period 2.




Primary Outcome Measures :
  1. Period 1: Maximum Plasma Concentration (Cmax) of Pitavastatin [ Time Frame: Period 1 Day 1 ]
  2. Period 1: Plasma Concentration Versus Time (Area Under the Curve, AUC0-inf) of Pitavastatin [ Time Frame: Period 1 Day 1 ]
  3. Period 1: Time to Maximum Concentration (Tmax) of Pitavastatin [ Time Frame: Period 1 Day 1 ]
  4. Period 1: Apparent Total Clearance (CL/F) of Pitavastatin [ Time Frame: Period 1 ]
  5. Period 1: Volume of Distribution (V/F) of Pitavastatin [ Time Frame: Period 1 Day 1 ]
  6. Period 1: Elimination Half-Life (T1/2) of Pitavastatin [ Time Frame: Period 1 Day 1 ]
  7. Period 2: Maximum Plasma Concentration (Cmax) of Pitavastatin [ Time Frame: Period 2 Day 4 ]
  8. Period 2: Plasma Concentration Versus Time (Area Under the Curve, AUC0-inf) of Pitavastatin [ Time Frame: Period 2 Day 4 ]
  9. Period 2: Time to Maximum Concentration (Tmax) of Pitavastatin [ Time Frame: Period 2 Day 4 ]
  10. Period 2: Apparent Total Clearance (CL/F) of Pitavastatin [ Time Frame: Period 2 Day 4 ]
  11. Period 2: Volume of Distribution (V/F) of Pitavastatin [ Time Frame: Period 2 Day 4 ]
  12. Period 2: Elimination Half-Life (T1/2) of Pitavastatin [ Time Frame: Period 2 Day 4 ]

Secondary Outcome Measures :
  1. Percentage of Participants With Adverse Events (AEs) [ Time Frame: From the start of Period 1 through safety follow-up (Period 2, Day 34) ]
    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.

  2. Period 2: Cmax of RO7049389 [ Time Frame: Period 2 Days 3-4 ]
  3. Period 2: AUC-tau of RO7049389 [ Time Frame: Period 2 Days 3-4 ]
  4. Period 1: Cmax of Pitavastatin Lactone [ Time Frame: Period 1 Day 1 ]
  5. Period 1: AUC0-inf of Pitavastatin Lactone [ Time Frame: Period 1 Day 1 ]
  6. Period 1: AUC Ratio of Pitavastatin Lactone to Pitavastatin [ Time Frame: Period 1 Day 1 ]
  7. Period 2: Cmax of Pitavastatin Lactone [ Time Frame: Period 2 Day 4 ]
  8. Period 2: AUC0-inf of Pitavastatin Lactone [ Time Frame: Period 2 Day 4 ]
  9. Period 2: AUC Ratio of Pitavastatin Lactone to Pitavastatin [ Time Frame: Period 2 Day 4 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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) </=6 months prior to the first dose of study drug or the expectation that such treatment will be needed at any time during the study
  • Are currently enrolled in or have participated in any other clinical study involving an investigational product or in any other type of medical research within the last 30 days or 5 half lives (whichever is longer)
  • Donation or loss of blood or blood products in excess of 500 mL within 3 months of screening and for the duration of the study
  • Positive test for drugs of abuse (including recreational drugs) and/or positive alcohol test and/or positive cotinine test at screening and on Day -1
  • Positive test at screening of any of the following: Hepatitis A virus (HAV IgM Ab), hepatitis B virus (HBsAg or HBcAb), hepatitis C virus (HCV RNA or HCV Ab) or human immunodeficiency virus (HIV-1 and HIV-2 Ab)
  • History of alcohol consumption exceeding 2 standard drinks per day on average (1 standard drink = 10 grams of alcohol) and/or drug abuse within 12 months of screening
  • Use of >5 cigarettes or equivalent nicotine-containing product per day prior to screening

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03717064


Locations
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United States, Florida
Covance Research Unit - Daytona
Daytona Beach, Florida, United States, 32117
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-LaRoche
  Study Documents (Full-Text)

Documents provided by Hoffmann-La Roche:

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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT03717064    
Other Study ID Numbers: YP40218
First Posted: October 24, 2018    Key Record Dates
Results First Posted: January 10, 2020
Last Update Posted: January 10, 2020
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pitavastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Lipid Regulating Agents