AtherosclerosisPhase 1NCT01995383
A Single Ascending Dose Study Investigating the Safety, Pharmacokinetics and Pharmacodynamics of RO6836191 in Healthy Male Volunteers.
A Phase 1 study testing LS followed by NS diet condition, NS followed by LS diet condition and RO6836191 in people with Atherosclerosis, run by Hoffmann-La Roche at 1 site in United States.
Trial summary
This single-center, randomized, placebo-controlled, double-blind study will assess the safety, pharmacokinetics and pharmacodynamics of RO6836191 in healthy male volunteers in two parts. Part 1 will assess the safety of oral single ascending doses of RO6836191 compared to placebo in fasted volunteers. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Atherosclerosis
- What is being tested?
- LS followed by NS diet condition, NS followed by LS diet condition and RO6836191
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to Jun 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male volunteers, aged 18 to 45 years old.
- No active or chronic disease following a detailed medical and surgical history and complete physical examination.
- A BMI between 18 to 30 kg/m2 inclusive.
- Use of a highly effective form of birth control for the duration of the study and until 90 days after the last dose.
Who cannot join
- Any clinically relevant current or history of conditions or illnesses.
- Clinically significant symptoms of infection within 5 days of the first dosing day or a history of recurrent infections.
- Any suspicion or history of alcohol abuse and/or consumption of other drugs of abuse.
- Smokers unable or unwilling to restrict to 5 cigarettes daily during the study and to not smoke during the stay at the clinic.
- Any cardiac abnormalities.
- Blood donation over 450 mL within three months prior to screening.
- Participation in an investigational drug or device study within 3 months prior to dosing.
- Corticosteroid use within 3 months prior to dosing.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Oral Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO6836191 in Healthy Male Subjects Including a Single Intravenous Microdose of RO6836191
This single-center, randomized, placebo-controlled, double-blind study will assess the safety, pharmacokinetics and pharmacodynamics of RO6836191 in healthy male volunteers in two parts. Part 1 will assess the safety of oral single ascending doses of RO6836191 compared to placebo in fasted volunteers. In Part 2, participants will be given two single oral doses of RO6836191 or placebo under low or normal-salt diet conditions. A subset of these participants will subsequently receive a single IV dose of RO6836191 for further analysis.
- Conditions
- Atherosclerosis
- Being tested
- LS followed by NS diet condition, NS followed by LS diet condition, Placebo, RO6836191
- Medical subject headings
- Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LS followed by NS diet conditionOther
LS diet period followed by NS diet period
NS followed by LS diet conditionOther
NS diet period followed by LS diet period
PlaceboDrug
Single oral administrations
PlaceboDrug
2 single oral administrations
RO6836191Drug
Orally administered, single ascending doses
RO6836191Drug
2 single oral doses
RO6836191Drug
Intravenous administration
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Placebo (PL) | Placebo comparator | Not described Receives: Drug: Placebo |
| Part 1: Single Ascending Doses (SAD) of RO6836191 | Experimental | Not described Receives: Drug: RO6836191 |
| Part 2: PL: Low-salt (LS) followed by normal-salt (NS) diet | Placebo comparator | Not described Receives: Other: LS followed by NS diet condition; Drug: Placebo; Drug: RO6836191 |
| Part 2: PL: NS followed by LS diet | Placebo comparator | Not described Receives: Other: NS followed by LS diet condition; Drug: Placebo; Drug: RO6836191 |
| Part 2: RO6836191: LS followed by NS diet | Experimental | Not described Receives: Other: LS followed by NS diet condition; Drug: RO6836191 |
| Part 2: RO6836191: NS followed by LS diet | Experimental | Not described Receives: Other: NS followed by LS diet condition; Drug: RO6836191 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 2: Area under the concentration-time curve (AUC)
Measured: Up to Day 35
Part 2: Plasma aldosterone levels
Measured: Up to 2 days after drug administration
Part 2: Urine aldosterone levels
Measured: Up to 3 days after drug administration
Part 1: Plasma aldosterone levels
Measured: Up to Day 5
Part 1: Urine aldosterone levels
Measured: Up to Day 3
Part 2: Incidence of AEs
Measured: Up to 12 weeks
Parts 1: Incidence of adverse events (AE)
Measured: Until Day 21
Secondary outcomes (1)
Part 2: Volume of distribution after intravenous administration
Measured: Days 28-37
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2013 (estimated)
- Study startNov 2013
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AtherosclerosisStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01995383
- Sponsor's protocol ID
- WP28586
- Status last verified
- Nov 2016
- First submitted
- 20 Nov 2013
- Last updated
- 4 Nov 2016
- Results posted
- No
Publications
Bogman K, Schwab D, Delporte ML, Palermo G, Amrein K, Mohr S, De Vera Mudry MC, Brown MJ, Ferber P. Preclinical and Early Clinical Profile of a Highly Selective and Potent Oral Inhibitor of Aldosterone Synthase (CYP11B2). Hypertension. 2017 Jan;69(1):189-196. doi: 10.1161/HYPERTENSIONAHA.116.07716. Epub 2016 Nov 21.
PubMed 27872236
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Oral Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO6836191 in Healthy Male Subjects Including a Single Intravenous Microdose of RO6836191
- ClinicalTrials.gov ID
- NCT01995383
- Acronym / sponsor ID
- WP28586
- Conditions
- Atherosclerosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Nov 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 26 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This single-center, randomized, placebo-controlled, double-blind study will assess the safety, pharmacokinetics and pharmacodynamics of RO6836191 in healthy male volunteers in two parts. Part 1 will assess the safety of oral single ascending doses of RO6836191 compared to placebo in fasted volunteers. In Part 2, participants will be given two single oral doses of RO6836191 or placebo under low or normal-salt diet conditions. A subset of these participants will subsequently receive a single IV dose of RO6836191 for further analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Part 1: Placebo (PL) | Placebo comparator | Drug: Placebo |
| Part 1: Single Ascending Doses (SAD) of RO6836191 | Experimental | Drug: RO6836191 |
| Part 2: PL: Low-salt (LS) followed by normal-salt (NS) diet | Placebo comparator | Other: LS followed by NS diet condition, Drug: Placebo, Drug: RO6836191 |
| Part 2: PL: NS followed by LS diet | Placebo comparator | Other: NS followed by LS diet condition, Drug: Placebo, Drug: RO6836191 |
| Part 2: RO6836191: LS followed by NS diet | Experimental | Other: LS followed by NS diet condition, Drug: RO6836191 |
| Part 2: RO6836191: NS followed by LS diet | Experimental | Other: NS followed by LS diet condition, Drug: RO6836191 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male volunteers, aged 18 to 45 years old.
- No active or chronic disease following a detailed medical and surgical history and complete physical examination.
- A BMI between 18 to 30 kg/m2 inclusive.
- Use of a highly effective form of birth control for the duration of the study and until 90 days after the last dose.
Key exclusion criteria (8 listed)
- Any clinically relevant current or history of conditions or illnesses.
- Clinically significant symptoms of infection within 5 days of the first dosing day or a history of recurrent infections.
- Any suspicion or history of alcohol abuse and/or consumption of other drugs of abuse.
- Smokers unable or unwilling to restrict to 5 cigarettes daily during the study and to not smoke during the stay at the clinic.
- Any cardiac abnormalities.
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 |
|---|---|---|
| LS followed by NS diet conditionLS diet period followed by NS diet period | Other | Part 2: PL: Low-salt (LS) followed by normal-salt (NS) diet, Part 2: RO6836191: LS followed by NS diet |
| NS followed by LS diet conditionNS diet period followed by LS diet period | Other | Part 2: PL: NS followed by LS diet, Part 2: RO6836191: NS followed by LS diet |
| PlaceboSingle oral administrations | Drug | Part 1: Placebo (PL) |
| Placebo2 single oral administrations | Drug | Part 2: PL: Low-salt (LS) followed by normal-salt (NS) diet, Part 2: PL: NS followed by LS diet |
| RO6836191Orally administered, single ascending doses | Drug | Part 1: Single Ascending Doses (SAD) of RO6836191 |
| RO68361912 single oral doses | Drug | Part 2: RO6836191: LS followed by NS diet, Part 2: RO6836191: NS followed by LS diet |
| RO6836191Intravenous administration | Drug | Part 2: PL: Low-salt (LS) followed by normal-salt (NS) diet, Part 2: PL: NS followed by LS diet, Part 2: RO6836191: LS followed by NS diet, Part 2: RO6836191: NS followed by LS diet |
Primary outcome
Part 2: Area under the concentration-time curve (AUC)
Time frame: Up to Day 35
Part 2: Plasma aldosterone levels
Time frame: Up to 2 days after drug administration
Part 2: Urine aldosterone levels
Time frame: Up to 3 days after drug administration
Part 1: Plasma aldosterone levels
Time frame: Up to Day 5
Part 1: Urine aldosterone levels
Time frame: Up to Day 3
Part 2: Incidence of AEs
Time frame: Up to 12 weeks
Parts 1: Incidence of adverse events (AE)
Time frame: Until Day 21
1 secondary outcome
Part 2: Volume of distribution after intravenous administration
Time frame: Days 28-37
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2016.
- Derived from this study: PubMed 27872236Bogman K, Schwab D, Delporte ML, Palermo G, Amrein K, Mohr S, De Vera Mudry MC, Brown MJ, Ferber P. Preclinical and Early Clinical Profile of a Highly Selective and Potent Oral Inhibitor of Aldosterone Synthase (CYP11B2). Hypertension. 2017 Jan;69(1):189-196. doi: 10.1161/HYPERTENSIONAHA.116.07716. Epub 2016 Nov 21.
Related trials for Atherosclerosis
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Active, not recruiting
SUCCESS (SelUtion, Safety, effiCaCy, hEalth economicS and promS) PTA Study
Peripheral Artery Disease
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
RecruitingPhase 3
Reducing Adverse Vascular Outcomes With Factor XI Inhibition in Adult Participants With Peripheral Artery Disease
Peripheral Artery Disease (PAD)
Recruiting
The THOR IDE Study
Peripheral Artery Disease, Peripheral Artery Stenosis
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-La Roche
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 LS followed by NS diet condition, NS followed by LS diet condition and RO6836191 in people with Atherosclerosis, 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 8 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 4 Nov 2016. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Part 2: Area under the concentration-time curve (AUC) (time frame: Up to Day 35). The study lists 7 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 NCT01995383, which also lists 1 linked publication.
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 4 Nov 2016.