Healthy VolunteersPhase 1NCT03717064

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

A Phase 1 study testing RO7049389 and Pitavastatin in people with Healthy Volunteers, run by Hoffmann-La Roche at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers
What is being tested?: RO7049389 and Pitavastatin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 18 participants
Where: 1 siteUnited States
Study dates: 7 Nov 2018to 17 Dec 2018
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 60 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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)

Show all 14Show fewer

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Covance Research Unit - Daytona
Daytona Beach, Florida, 32117

Other trials in United States

About this study

Official title: An Open-Label, Fixed Sequence, Two-Period Study to Investigate the Effect of RO7049389 on the Pharmacokinetics of Pitavastatin in Healthy Volunteers

Conditions: Healthy Volunteers
Being tested: RO7049389, Pitavastatin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RO7049389Drug
RO7049389 will be taken orally, in tablet form, BID on Days 1-6 of Period 2.
PitavastatinDrug
Pitavastatin will be taken orally, in tablet form, once on Day 1 of Period 1, and once on Day 4 of Period 2.

Study groups in NCT03717064
Study group	Role	What they receive
Pitavastatin	Experimental	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. Receives: Drug: RO7049389; Drug: Pitavastatin

What is being measured

The primary outcome is the main question the study is designed to answer.

Period 1: Maximum Plasma Concentration (Cmax) of Pitavastatin
Measured: Period 1 Day 1
Period 1: Plasma Concentration Versus Time (Area Under the Curve, AUC0-inf) of Pitavastatin
Measured: Period 1 Day 1
Period 1: Time to Maximum Concentration (Tmax) of Pitavastatin
Measured: Period 1 Day 1
Period 1: Apparent Total Clearance (CL/F) of Pitavastatin
Measured: Period 1
Period 1: Volume of Distribution (V/F) of Pitavastatin
Measured: Period 1 Day 1
Period 1: Elimination Half-Life (T1/2) of Pitavastatin
Measured: Period 1 Day 1
Period 2: Maximum Plasma Concentration (Cmax) of Pitavastatin
Measured: Period 2 Day 4
Period 2: Plasma Concentration Versus Time (Area Under the Curve, AUC0-inf) of Pitavastatin
Measured: Period 2 Day 4
Period 2: Time to Maximum Concentration (Tmax) of Pitavastatin
Measured: Period 2 Day 4
Period 2: Apparent Total Clearance (CL/F) of Pitavastatin
Measured: Period 2 Day 4
Period 2: Volume of Distribution (V/F) of Pitavastatin
Measured: Period 2 Day 4
Period 2: Elimination Half-Life (T1/2) of Pitavastatin
Measured: Period 2 Day 4

Secondary outcomes (9)

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.
Measured: From the start of Period 1 through safety follow-up (Period 2, Day 34)
Period 2: Cmax of RO7049389
Measured: Period 2 Days 3-4
Period 2: AUC-tau of RO7049389
Measured: Period 2 Days 3-4
Period 1: Cmax of Pitavastatin Lactone
Measured: Period 1 Day 1
Period 1: AUC0-inf of Pitavastatin Lactone
Measured: Period 1 Day 1
Period 1: AUC Ratio of Pitavastatin Lactone to Pitavastatin
Measured: Period 1 Day 1
Period 2: Cmax of Pitavastatin Lactone
Measured: Period 2 Day 4
Period 2: AUC0-inf of Pitavastatin Lactone
Measured: Period 2 Day 4
Period 2: AUC Ratio of Pitavastatin Lactone to Pitavastatin
Measured: Period 2 Day 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Nov 201817 Dec 2018

First posted24 Oct 2018
Study start7 Nov 2018
Primary completion17 Dec 2018
Study completion17 Dec 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Healthy VolunteersStudies of the same condition, open and under way.
More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03717064
Sponsor's protocol ID: YP40218
Status last verified: Dec 2019
First submitted: 22 Oct 2018
Last updated: 10 Jan 2020
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 10 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-Label, Fixed Sequence, Two-Period Study to Investigate the Effect of RO7049389 on the Pharmacokinetics of Pitavastatin in Healthy Volunteers
ClinicalTrials.gov ID: NCT03717064
Acronym / sponsor ID: YP40218
Conditions: Healthy Volunteers
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 18 participants (actual)
Lead sponsor: Hoffmann-La RocheIndustry (pharma, biotech, devices)
Study start: 7 Nov 2018 (actual)
Primary completion: 17 Dec 2018 (actual)
Study completion: 17 Dec 2018 (actual)
First posted: 24 Oct 2018 (actual)
Results: Posted 10 Jan 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Pitavastatin	Experimental	Drug: RO7049389, Drug: PitavastatinPeriod 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.

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (14 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
RO7049389RO7049389 will be taken orally, in tablet form, BID on Days 1-6 of Period 2.	Drug	Pitavastatin
PitavastatinPitavastatin will be taken orally, in tablet form, once on Day 1 of Period 1, and once on Day 4 of Period 2.	Drug	Pitavastatin

Primary outcome

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

9 secondary outcomes

Percentage of Participants With Adverse Events (AEs)
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

Results and safety

Results posted to the registry on 10 Jan 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Pitavastatin/RO7049389	18	18

Primary outcome: Period 1: Maximum Plasma Concentration (Cmax) of Pitavastatin

Time frame: Period 1 Day 1. Geometric mean (Geometric Coefficient of Variation). Unit: ng/mL

Measure	Pitavastatin/RO7049389 n = 17
Value	23.8 (42.7)

Primary outcome: Period 1: Plasma Concentration Versus Time (Area Under the Curve, AUC0-inf) of Pitavastatin

Time frame: Period 1 Day 1. Geometric mean (Geometric Coefficient of Variation). Unit: h*ng/mL

Measure	Pitavastatin/RO7049389 n = 17
Value	78.6 (41)

Primary outcome: Period 1: Time to Maximum Concentration (Tmax) of Pitavastatin

Time frame: Period 1 Day 1. Median (Full Range). Unit: hours (h)

Measure	Pitavastatin/RO7049389 n = 17
Value	1.5 (0.5 to 2)

Primary outcome: Period 1: Apparent Total Clearance (CL/F) of Pitavastatin

Time frame: Period 1. Geometric mean (Geometric Coefficient of Variation). Unit: L/h

Measure	Pitavastatin/RO7049389 n = 17
Value	25.4 (39.9)

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: From the start of Period 1 through safety follow-up (Period 2, Day 34). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pitavastatin/RO7049389	0 of 18 (0%)	7 of 18 (38.9%)	0 of 18

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Clinical Trials study director

Hoffmann-LaRoche

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing RO7049389 and Pitavastatin in people with Healthy Volunteers, run by Hoffmann-La Roche at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Period 1: Maximum Plasma Concentration (Cmax) of Pitavastatin (time frame: Period 1 Day 1). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03717064.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2020.