ClinicalTrials.gg
CompletedNCT03717064Updated Jan 10, 2020Results posted

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

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

Phase
Phase 1
Study type
Interventional
Enrollment
18
Allocation
Non-randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Healthy Volunteers
03

In context

Lead sponsor

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.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
18 participants (actual)

Study arms

  • 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 · Drug: Pitavastatin

Interventions

  • 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.

06

What researchers measure

Primary outcomes

  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 outcomes

  1. 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)

  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

07

Results

Posted Jan 10, 2020

Participant flow

This study recruited healthy adult participants at one site in the United States.

Period 1
Participant flow — Period 1
MilestonePitavastatin/RO7049389
Started18
Completed18
Not completed0
Period 2
Participant flow — Period 2
MilestonePitavastatin/RO7049389
Started18
Completed17
Not completed1
Withdrew: Adverse event1

Outcome measures

PrimaryPeriod 1: Maximum Plasma Concentration (Cmax) of Pitavastatin
Time frame:
Period 1 Day 1
Reported as:
Geometric mean · ng/mL
Period 1: Maximum Plasma Concentration (Cmax) of Pitavastatin
ng/mLPitavastatin/RO7049389
Period 1: Maximum Plasma Concentration (Cmax) of Pitavastatin23.8 ± 42.7
PrimaryPeriod 1: Plasma Concentration Versus Time (Area Under the Curve, AUC0-inf) of Pitavastatin
Time frame:
Period 1 Day 1
Reported as:
Geometric mean · h*ng/mL
Period 1: Plasma Concentration Versus Time (Area Under the Curve, AUC0-inf) of Pitavastatin
h*ng/mLPitavastatin/RO7049389
Period 1: Plasma Concentration Versus Time (Area Under the Curve, AUC0-inf) of Pitavastatin78.6 ± 41
PrimaryPeriod 1: Time to Maximum Concentration (Tmax) of Pitavastatin
Time frame:
Period 1 Day 1
Reported as:
Median · hours (h)
Period 1: Time to Maximum Concentration (Tmax) of Pitavastatin
hours (h)Pitavastatin/RO7049389
Period 1: Time to Maximum Concentration (Tmax) of Pitavastatin1.5 (0.5 to 2)
PrimaryPeriod 1: Apparent Total Clearance (CL/F) of Pitavastatin
Time frame:
Period 1
Reported as:
Geometric mean · L/h
Period 1: Apparent Total Clearance (CL/F) of Pitavastatin
L/hPitavastatin/RO7049389
Period 1: Apparent Total Clearance (CL/F) of Pitavastatin25.4 ± 39.9
PrimaryPeriod 1: Volume of Distribution (V/F) of Pitavastatin
Time frame:
Period 1 Day 1
Reported as:
Geometric mean · Liters (L)
Period 1: Volume of Distribution (V/F) of Pitavastatin
Liters (L)Pitavastatin/RO7049389
Period 1: Volume of Distribution (V/F) of Pitavastatin525 ± 41.3
PrimaryPeriod 1: Elimination Half-Life (T1/2) of Pitavastatin
Time frame:
Period 1 Day 1
Reported as:
Geometric mean · h
Period 1: Elimination Half-Life (T1/2) of Pitavastatin
hPitavastatin/RO7049389
Period 1: Elimination Half-Life (T1/2) of Pitavastatin14.3 ± 32.4
PrimaryPeriod 2: Maximum Plasma Concentration (Cmax) of Pitavastatin
Time frame:
Period 2 Day 4
Reported as:
Geometric mean · ng/mL
Period 2: Maximum Plasma Concentration (Cmax) of Pitavastatin
ng/mLPitavastatin/RO7049389
Period 2: Maximum Plasma Concentration (Cmax) of Pitavastatin33.5 ± 52.7
PrimaryPeriod 2: Plasma Concentration Versus Time (Area Under the Curve, AUC0-inf) of Pitavastatin
Time frame:
Period 2 Day 4
Reported as:
Geometric mean · h*ng/mL
Period 2: Plasma Concentration Versus Time (Area Under the Curve, AUC0-inf) of Pitavastatin
h*ng/mLPitavastatin/RO7049389
Period 2: Plasma Concentration Versus Time (Area Under the Curve, AUC0-inf) of Pitavastatin129 ± 50.7
PrimaryPeriod 2: Time to Maximum Concentration (Tmax) of Pitavastatin
Time frame:
Period 2 Day 4
Reported as:
Median · h
Period 2: Time to Maximum Concentration (Tmax) of Pitavastatin
hPitavastatin/RO7049389
Period 2: Time to Maximum Concentration (Tmax) of Pitavastatin2 (0.5 to 4)
PrimaryPeriod 2: Apparent Total Clearance (CL/F) of Pitavastatin
Time frame:
Period 2 Day 4
Reported as:
Geometric mean · L/h
Period 2: Apparent Total Clearance (CL/F) of Pitavastatin
L/hPitavastatin/RO7049389
Period 2: Apparent Total Clearance (CL/F) of Pitavastatin15.6 ± 45
PrimaryPeriod 2: Volume of Distribution (V/F) of Pitavastatin
Time frame:
Period 2 Day 4
Reported as:
Geometric mean · L
Period 2: Volume of Distribution (V/F) of Pitavastatin
LPitavastatin/RO7049389
Period 2: Volume of Distribution (V/F) of Pitavastatin220 ± 59.3
PrimaryPeriod 2: Elimination Half-Life (T1/2) of Pitavastatin
Time frame:
Period 2 Day 4
Reported as:
Geometric mean · h
Period 2: Elimination Half-Life (T1/2) of Pitavastatin
hPitavastatin/RO7049389
Period 2: Elimination Half-Life (T1/2) of Pitavastatin9.78 ± 49
SecondaryPercentage 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)
Reported as:
Number · Percentage of Participants
Percentage of Participants With Adverse Events (AEs)
Percentage of ParticipantsPitavastatin/RO7049389
Percentage of Participants With Adverse Events (AEs)39
SecondaryPeriod 2: Cmax of RO7049389
Time frame:
Period 2 Days 3-4
Reported as:
Geometric mean · ng/mL
Period 2: Cmax of RO7049389
ng/mLPitavastatin/RO7049389
RO704938915400 ± 58.1
RO7049389 + Pitavastatin17600 ± 48.4
SecondaryPeriod 2: AUC-tau of RO7049389
Time frame:
Period 2 Days 3-4
Reported as:
Geometric mean · h*ng/mL
Period 2: AUC-tau of RO7049389
h*ng/mLPitavastatin/RO7049389
RO704938962700 ± 92.8
RO7049389 + Pitavastatin68500 ± 81.8
SecondaryPeriod 1: Cmax of Pitavastatin Lactone
Time frame:
Period 1 Day 1
Reported as:
Geometric mean · ng/mL
Period 1: Cmax of Pitavastatin Lactone
ng/mLPitavastatin/RO7049389
Period 1: Cmax of Pitavastatin Lactone14.4 ± 23.5
SecondaryPeriod 1: AUC0-inf of Pitavastatin Lactone
Time frame:
Period 1 Day 1
Reported as:
Geometric mean · h*ng/mL
Period 1: AUC0-inf of Pitavastatin Lactone
h*ng/mLPitavastatin/RO7049389
Period 1: AUC0-inf of Pitavastatin Lactone193 ± 27.4
SecondaryPeriod 1: AUC Ratio of Pitavastatin Lactone to Pitavastatin
Time frame:
Period 1 Day 1
Reported as:
Geometric mean · Ratio
Period 1: AUC Ratio of Pitavastatin Lactone to Pitavastatin
RatioPitavastatin/RO7049389
Period 1: AUC Ratio of Pitavastatin Lactone to Pitavastatin2.45 (2.17 to 2.78)
SecondaryPeriod 2: Cmax of Pitavastatin Lactone
Time frame:
Period 2 Day 4
Reported as:
Geometric mean · ng/mL
Period 2: Cmax of Pitavastatin Lactone
ng/mLPitavastatin/RO7049389
Period 2: Cmax of Pitavastatin Lactone6.39 ± 24.4
SecondaryPeriod 2: AUC0-inf of Pitavastatin Lactone
Time frame:
Period 2 Day 4
Reported as:
Geometric mean · h*ng/mL
Period 2: AUC0-inf of Pitavastatin Lactone
h*ng/mLPitavastatin/RO7049389
Period 2: AUC0-inf of Pitavastatin Lactone81.7 ± 19.9
SecondaryPeriod 2: AUC Ratio of Pitavastatin Lactone to Pitavastatin
Time frame:
Period 2 Day 4
Reported as:
Geometric mean · Ratio
Period 2: AUC Ratio of Pitavastatin Lactone to Pitavastatin
RatioPitavastatin/RO7049389
Period 2: AUC Ratio of Pitavastatin Lactone to Pitavastatin0.636 (0.504 to 0.802)

Adverse events

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.

Adverse event summary by group
GroupDeathsSeriousOther
Pitavastatin/RO70493890/18 (0%)0/18 (0%)7/18 (38.9%)
Most frequent other events
Most frequent other events
EventPitavastatin/RO7049389
HeadacheNervous system disorders3/18
NauseaGastrointestinal disorders2/18
DizzinessNervous system disorders2/18
Hypoaesthesia oralGastrointestinal disorders1/18
VomitingGastrointestinal disorders1/18
FatigueGeneral disorders1/18
Musculoskeletal painMusculoskeletal and connective tissue disorders1/18
RhinorrhoeaRespiratory, thoracic and mediastinal disorders1/18

Baseline characteristics

Age, Continuous
Age, Continuous(Years)Pitavastatin/RO7049389
Mean39.2 ± 14.5
Sex: Female, Male
Sex: Female, Male(Participants)Pitavastatin/RO7049389
Female7
Male11
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Pitavastatin/RO7049389
Hispanic or Latino8
Not Hispanic or Latino10
Unknown or Not Reported0
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Pitavastatin/RO7049389
American Indian or Alaska Native0
Asian0
Native Hawaiian or Other Pacific Islander0
Black or African American5
White13
More than one race0
Unknown or Not Reported0
08

Study locations

1 site
  • Covance Research Unit - Daytona
    Daytona Beach, Florida 32117, United States
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Aug 27, 2018

Documents are hosted by the registry — open the source record to download them.

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Nov 2018 to primary completion in Dec 2018, 1 month.

Results were first posted in Jan 2020, 1 year after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 22, 2018
First posted
Oct 24, 2018
StartActual
Nov 7, 2018
Primary completionActual
Dec 17, 2018
CompletionActual
Dec 17, 2018
Results first posted
Jan 10, 2020
Last update
Jan 10, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 10, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03717064
Lead sponsor
Hoffmann-La Roche
Responsible party
Sponsor
First posted
Oct 24, 2018
Start date
Nov 7, 2018
Primary completion
Dec 17, 2018
Completion
Dec 17, 2018
Results posted
Jan 10, 2020
Last update
Jan 10, 2020

Study contacts

Clinical Trials
study director · Hoffmann-LaRoche

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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