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

• Sponsor: Hoffmann-La Roche (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03717064
• Collaborator: (none)
• Enrollment: 18
• Location: 1
• Arm: 1
• Actual Duration (Months): 1.3
• Patients Per Site Per Month: 13.7

Study Details

Study Description

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

Study Design

• Study Type: Interventional
• 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: Nov 7, 2018
• Actual Primary Completion Date: Dec 17, 2018
• Actual Study Completion Date: Dec 17, 2018

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Period 1: Maximum Plasma Concentration (Cmax) of Pitavastatin [Period 1 Day 1]

2. Period 1: Plasma Concentration Versus Time (Area Under the Curve, AUC0-inf) of Pitavastatin [Period 1 Day 1]

3. Period 1: Time to Maximum Concentration (Tmax) of Pitavastatin [Period 1 Day 1]

4. Period 1: Apparent Total Clearance (CL/F) of Pitavastatin [Period 1]

5. Period 1: Volume of Distribution (V/F) of Pitavastatin [Period 1 Day 1]

6. Period 1: Elimination Half-Life (T1/2) of Pitavastatin [Period 1 Day 1]

7. Period 2: Maximum Plasma Concentration (Cmax) of Pitavastatin [Period 2 Day 4]

8. Period 2: Plasma Concentration Versus Time (Area Under the Curve, AUC0-inf) of Pitavastatin [Period 2 Day 4]

9. Period 2: Time to Maximum Concentration (Tmax) of Pitavastatin [Period 2 Day 4]

10. Period 2: Apparent Total Clearance (CL/F) of Pitavastatin [Period 2 Day 4]

11. Period 2: Volume of Distribution (V/F) of Pitavastatin [Period 2 Day 4]

12. Period 2: Elimination Half-Life (T1/2) of Pitavastatin [Period 2 Day 4]

Secondary Outcome Measures

1. Percentage of Participants With Adverse Events (AEs) [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 [Period 2 Days 3-4]

3. Period 2: AUC-tau of RO7049389 [Period 2 Days 3-4]

4. Period 1: Cmax of Pitavastatin Lactone [Period 1 Day 1]

5. Period 1: AUC0-inf of Pitavastatin Lactone [Period 1 Day 1]

6. Period 1: AUC Ratio of Pitavastatin Lactone to Pitavastatin [Period 1 Day 1]

7. Period 2: Cmax of Pitavastatin Lactone [Period 2 Day 4]

8. Period 2: AUC0-inf of Pitavastatin Lactone [Period 2 Day 4]

9. Period 2: AUC Ratio of Pitavastatin Lactone to Pitavastatin [Period 2 Day 4]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Covance Research Unit - Daytona	Daytona Beach	Florida	United States	32117

Sponsors and Collaborators

• Hoffmann-La Roche

Investigators

• Study Director: Clinical Trials, Hoffmann-LaRoche

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Aug 27, 2018

More Information

Publications

None provided.

• Responsible Party: Hoffmann-La Roche
• ClinicalTrials.gov Identifier: NCT03717064
• Other Study ID Numbers: YP40218
• First Posted: Oct 24, 2018
• Last Update Posted: Jan 10, 2020
• Last Verified: Dec 1, 2019

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Pitavastatin

Study Results

Participant Flow

Recruitment Details	This study recruited healthy adult participants at one site in the United States.
Pre-assignment Detail	This study had two periods. Period 1: Participants received a single dose of pitavastatin, followed by a washout period of 7-21 days. Period 2: Participants received a single dose of pitavastatin along with a twice-daily dose of RO7049389.

Arm/Group Title	Pitavastatin/RO7049389
Arm/Group Description	Period 1: Participants received a single dose of pitavastatin on Day 1, followed by a wash-out period of at least 7 days and up to 21 days. Period 2: Participants received RO7049389 on Days 1-6. Participants also received a single dose of pitavastatin on Day 4.
Period Title: Period 1
STARTED	18
COMPLETED	18
NOT COMPLETED	0
Period Title: Period 1
STARTED	18
COMPLETED	17
NOT COMPLETED	1

Baseline Characteristics

Arm/Group Title	Pitavastatin/RO7049389
Arm/Group Description	Period 1: Participants received a single dose of pitavastatin on Day 1, followed by a wash-out period of at least 7 days and up to 21 days. Period 2: Participants received RO7049389 on Days 1-6. Participants also received a single dose of pitavastatin on Day 4.
Overall Participants	18
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	39.2 (14.5)
Sex: Female, Male (Count of Participants)
Female	7 38.9%
Male	11 61.1%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	8 44.4%
Not Hispanic or Latino	10 55.6%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	5 27.8%
White	13 72.2%
More than one race	0 0%
Unknown or Not Reported	0 0%

Outcome Measures

1. Primary Outcome

Title	Period 1: Maximum Plasma Concentration (Cmax) of Pitavastatin
Time Frame	Period 1 Day 1

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pitavastatin/RO7049389
Arm/Group Description	Period 1: Participants received a single dose of pitavastatin on Day 1, followed by a wash-out period of at least 7 days and up to 21 days. Period 2: Participants received RO7049389 on Days 1-6. Participants also received a single dose of pitavastatin on Day 4.
Measure Participants	17
Geometric Mean (Geometric Coefficient of Variation) [ng/mL]	23.8 (42.7)

2. Primary Outcome

Title	Period 1: Plasma Concentration Versus Time (Area Under the Curve, AUC0-inf) of Pitavastatin
Time Frame	Period 1 Day 1

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pitavastatin/RO7049389
Arm/Group Description	Period 1: Participants received a single dose of pitavastatin on Day 1, followed by a wash-out period of at least 7 days and up to 21 days. Period 2: Participants received RO7049389 on Days 1-6. Participants also received a single dose of pitavastatin on Day 4.
Measure Participants	17
Geometric Mean (Geometric Coefficient of Variation) [h*ng/mL]	78.6 (41)

3. Primary Outcome

Title	Period 1: Time to Maximum Concentration (Tmax) of Pitavastatin
Time Frame	Period 1 Day 1

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pitavastatin/RO7049389
Arm/Group Description	Period 1: Participants received a single dose of pitavastatin on Day 1, followed by a wash-out period of at least 7 days and up to 21 days. Period 2: Participants received RO7049389 on Days 1-6. Participants also received a single dose of pitavastatin on Day 4.
Measure Participants	17
Median (Full Range) [hours (h)]	1.5

4. Primary Outcome

Title	Period 1: Apparent Total Clearance (CL/F) of Pitavastatin
Time Frame	Period 1

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pitavastatin/RO7049389
Arm/Group Description	Period 1: Participants received a single dose of pitavastatin on Day 1, followed by a wash-out period of at least 7 days and up to 21 days. Period 2: Participants received RO7049389 on Days 1-6. Participants also received a single dose of pitavastatin on Day 4.
Measure Participants	17
Geometric Mean (Geometric Coefficient of Variation) [L/h]	25.4 (39.9)

5. Primary Outcome

Title	Period 1: Volume of Distribution (V/F) of Pitavastatin
Time Frame	Period 1 Day 1

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pitavastatin/RO7049389
Arm/Group Description	Period 1: Participants received a single dose of pitavastatin on Day 1, followed by a wash-out period of at least 7 days and up to 21 days. Period 2: Participants received RO7049389 on Days 1-6. Participants also received a single dose of pitavastatin on Day 4.
Measure Participants	17
Geometric Mean (Geometric Coefficient of Variation) [Liters (L)]	525 (41.3)

6. Primary Outcome

Title	Period 1: Elimination Half-Life (T1/2) of Pitavastatin
Time Frame	Period 1 Day 1

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pitavastatin/RO7049389
Arm/Group Description	Period 1: Participants received a single dose of pitavastatin on Day 1, followed by a wash-out period of at least 7 days and up to 21 days. Period 2: Participants received RO7049389 on Days 1-6. Participants also received a single dose of pitavastatin on Day 4.
Measure Participants	17
Geometric Mean (Geometric Coefficient of Variation) [h]	14.3 (32.4)

7. Primary Outcome

Title	Period 2: Maximum Plasma Concentration (Cmax) of Pitavastatin
Time Frame	Period 2 Day 4

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pitavastatin/RO7049389
Arm/Group Description	Period 1: Participants received a single dose of pitavastatin on Day 1, followed by a wash-out period of at least 7 days and up to 21 days. Period 2: Participants received RO7049389 on Days 1-6. Participants also received a single dose of pitavastatin on Day 4.
Measure Participants	17
Geometric Mean (Geometric Coefficient of Variation) [ng/mL]	33.5 (52.7)

8. Primary Outcome

Title	Period 2: Plasma Concentration Versus Time (Area Under the Curve, AUC0-inf) of Pitavastatin
Time Frame	Period 2 Day 4

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pitavastatin/RO7049389
Arm/Group Description	Period 1: Participants received a single dose of pitavastatin on Day 1, followed by a wash-out period of at least 7 days and up to 21 days. Period 2: Participants received RO7049389 on Days 1-6. Participants also received a single dose of pitavastatin on Day 4.
Measure Participants	17
Geometric Mean (Geometric Coefficient of Variation) [h*ng/mL]	129 (50.7)

9. Primary Outcome

Title	Period 2: Time to Maximum Concentration (Tmax) of Pitavastatin
Time Frame	Period 2 Day 4

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pitavastatin/RO7049389
Arm/Group Description	Period 1: Participants received a single dose of pitavastatin on Day 1, followed by a wash-out period of at least 7 days and up to 21 days. Period 2: Participants received RO7049389 on Days 1-6. Participants also received a single dose of pitavastatin on Day 4.
Measure Participants	17
Median (Full Range) [h]	2

10. Primary Outcome

Title	Period 2: Apparent Total Clearance (CL/F) of Pitavastatin
Time Frame	Period 2 Day 4

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pitavastatin/RO7049389
Arm/Group Description	Period 1: Participants received a single dose of pitavastatin on Day 1, followed by a wash-out period of at least 7 days and up to 21 days. Period 2: Participants received RO7049389 on Days 1-6. Participants also received a single dose of pitavastatin on Day 4.
Measure Participants	17
Geometric Mean (Geometric Coefficient of Variation) [L/h]	15.6 (45)

11. Primary Outcome

Title	Period 2: Volume of Distribution (V/F) of Pitavastatin
Time Frame	Period 2 Day 4

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pitavastatin/RO7049389
Arm/Group Description	Period 1: Participants received a single dose of pitavastatin on Day 1, followed by a wash-out period of at least 7 days and up to 21 days. Period 2: Participants received RO7049389 on Days 1-6. Participants also received a single dose of pitavastatin on Day 4.
Measure Participants	17
Geometric Mean (Geometric Coefficient of Variation) [L]	220 (59.3)

12. Primary Outcome

Title	Period 2: Elimination Half-Life (T1/2) of Pitavastatin
Time Frame	Period 2 Day 4

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pitavastatin/RO7049389
Arm/Group Description	Period 1: Participants received a single dose of pitavastatin on Day 1, followed by a wash-out period of at least 7 days and up to 21 days. Period 2: Participants received RO7049389 on Days 1-6. Participants also received a single dose of pitavastatin on Day 4.
Measure Participants	17
Geometric Mean (Geometric Coefficient of Variation) [h]	9.78 (49)

13. Secondary Outcome

Title	Percentage of Participants With Adverse Events (AEs)
Description	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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pitavastatin/RO7049389
Arm/Group Description	Period 1: Participants received a single dose of pitavastatin on Day 1, followed by a wash-out period of at least 7 days and up to 21 days. Period 2: Participants received RO7049389 on Days 1-6. Participants also received a single dose of pitavastatin on Day 4.
Measure Participants	18
Number [Percentage of Participants]	39 216.7%

14. Secondary Outcome

Title	Period 2: Cmax of RO7049389
Time Frame	Period 2 Days 3-4

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pitavastatin/RO7049389
Arm/Group Description	Period 1: Participants received a single dose of pitavastatin on Day 1, followed by a wash-out period of at least 7 days and up to 21 days. Period 2: Participants received RO7049389 on Days 1-6. Participants also received a single dose of pitavastatin on Day 4.
Measure Participants	17
RO7049389	15400 (58.1)
RO7049389 + Pitavastatin	17600 (48.4)

15. Secondary Outcome

Title	Period 2: AUC-tau of RO7049389
Time Frame	Period 2 Days 3-4

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pitavastatin/RO7049389
Arm/Group Description	Period 1: Participants received a single dose of pitavastatin on Day 1, followed by a wash-out period of at least 7 days and up to 21 days. Period 2: Participants received RO7049389 on Days 1-6. Participants also received a single dose of pitavastatin on Day 4.
Measure Participants	17
RO7049389	62700 (92.8)
RO7049389 + Pitavastatin	68500 (81.8)

16. Secondary Outcome

Title	Period 1: Cmax of Pitavastatin Lactone
Time Frame	Period 1 Day 1

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pitavastatin/RO7049389
Arm/Group Description	Period 1: Participants received a single dose of pitavastatin on Day 1, followed by a wash-out period of at least 7 days and up to 21 days. Period 2: Participants received RO7049389 on Days 1-6. Participants also received a single dose of pitavastatin on Day 4.
Measure Participants	17
Geometric Mean (Geometric Coefficient of Variation) [ng/mL]	14.4 (23.5)

17. Secondary Outcome

Title	Period 1: AUC0-inf of Pitavastatin Lactone
Time Frame	Period 1 Day 1

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pitavastatin/RO7049389
Arm/Group Description	Period 1: Participants received a single dose of pitavastatin on Day 1, followed by a wash-out period of at least 7 days and up to 21 days. Period 2: Participants received RO7049389 on Days 1-6. Participants also received a single dose of pitavastatin on Day 4.
Measure Participants	17
Geometric Mean (Geometric Coefficient of Variation) [h*ng/mL]	193 (27.4)

18. Secondary Outcome

Title	Period 1: AUC Ratio of Pitavastatin Lactone to Pitavastatin
Time Frame	Period 1 Day 1

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pitavastatin/RO7049389
Arm/Group Description	Period 1: Participants received a single dose of pitavastatin on Day 1, followed by a wash-out period of at least 7 days and up to 21 days. Period 2: Participants received RO7049389 on Days 1-6. Participants also received a single dose of pitavastatin on Day 4.
Measure Participants	17
Geometric Mean (90% Confidence Interval) [Ratio]	2.45

19. Secondary Outcome

Title	Period 2: Cmax of Pitavastatin Lactone
Time Frame	Period 2 Day 4

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pitavastatin/RO7049389
Arm/Group Description	Period 1: Participants received a single dose of pitavastatin on Day 1, followed by a wash-out period of at least 7 days and up to 21 days. Period 2: Participants received RO7049389 on Days 1-6. Participants also received a single dose of pitavastatin on Day 4.
Measure Participants	17
Geometric Mean (Geometric Coefficient of Variation) [ng/mL]	6.39 (24.4)

20. Secondary Outcome

Title	Period 2: AUC0-inf of Pitavastatin Lactone
Time Frame	Period 2 Day 4

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pitavastatin/RO7049389
Arm/Group Description	Period 1: Participants received a single dose of pitavastatin on Day 1, followed by a wash-out period of at least 7 days and up to 21 days. Period 2: Participants received RO7049389 on Days 1-6. Participants also received a single dose of pitavastatin on Day 4.
Measure Participants	17
Geometric Mean (Geometric Coefficient of Variation) [h*ng/mL]	81.7 (19.9)

21. Secondary Outcome

Title	Period 2: AUC Ratio of Pitavastatin Lactone to Pitavastatin
Time Frame	Period 2 Day 4

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pitavastatin/RO7049389
Arm/Group Description	Period 1: Participants received a single dose of pitavastatin on Day 1, followed by a wash-out period of at least 7 days and up to 21 days. Period 2: Participants received RO7049389 on Days 1-6. Participants also received a single dose of pitavastatin on Day 4.
Measure Participants	17
Geometric Mean (90% Confidence Interval) [Ratio]	0.636

Adverse Events

Time Frame	From the start of Period 1 through safety follow-up (Period 2, Day 34)
Arm/Group Title	Pitavastatin/RO7049389
Arm/Group Description	Period 1: Participants received a single dose of pitavastatin on Day 1, followed by a wash-out period of at least 7 days and up to 21 days. Period 2: Participants received RO7049389 on Days 1-6. Participants also received a single dose of pitavastatin on Day 4.
All Cause Mortality
	Pitavastatin/RO7049389
	Affected / at Risk (%)	# Events
Total	0/18 (0%)
Serious Adverse Events
	Pitavastatin/RO7049389
	Affected / at Risk (%)	# Events
Total	0/18 (0%)
Other (Not Including Serious) Adverse Events
	Pitavastatin/RO7049389
	Affected / at Risk (%)	# Events
Total	7/18 (38.9%)
Gastrointestinal disorders
Hypoaesthesia oral	1/18 (5.6%)	1
Nausea	2/18 (11.1%)	2
Vomiting	1/18 (5.6%)	1
General disorders
Fatigue	1/18 (5.6%)	1
Musculoskeletal and connective tissue disorders
Musculoskeletal pain	1/18 (5.6%)	1
Nervous system disorders
Dizziness	2/18 (11.1%)	2
Headache	3/18 (16.7%)	3
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea	1/18 (5.6%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.