Healthy VolunteerPhase 1NCT02015715
A Study Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics of RO6864018 in Male, Healthy, Asian Participants
A Phase 1 study testing RO6864018 in people with Healthy Volunteer, run by Hoffmann-La Roche at 2 sites in Singapore.
Trial summary
This randomized, double-blind, placebo-controlled, single ascending dose study will assess the safety, pharmacokinetics, and pharmacodynamics of RO6864018 in healthy, male, Asian and Caucasian participants. Read more about this study
- Who is it for?
- Ages 21 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- RO6864018
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 2 sitesSingapore
- Study dates
- Dec 2013to Nov 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 21 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy male participants of ethnic Chinese, Korean, Japanese origin or Caucasian
- No signs of any active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead electrocardiogram (ECG), hematology, blood chemistry, serology and urinalysis
- Body Mass Index (BMI) between 18 to 30 kilograms per square meter (kg/m^2) inclusive, and a weight range of 50 to 100 kilograms (kg) (110 to 220 pounds [lb]) inclusive at screening
- Non-smokers, or use of less than (<) 10 cigarettes (or equivalent nicotine-containing product) per day
Who cannot join
- History or symptoms of any significant disease
- Personal or family history of congenital long QT syndrome or sudden death
- Any confirmed significant allergic reactions against any drug, or multiple drug allergies (non-active hay fever is acceptable)
- Positive results for anti-nuclear antibody (ANA), anti-mitochondrial antibody (AMA), anti-smooth muscle antibody (ASMA) and thyroid peroxidase antibody
- Suspicion of regular consumption of drug of abuse
- History (within 3 months of screening) of alcohol consumption exceeding 14 units per week on average (1 unit = 10 grams of alcohol)
Show all 11Show fewer
- Participants who have received Interferon (IFN) or peginterferon within 8 weeks prior to dosing
- Use of any medication (prescription or over the counter [OTC], including health supplements and herbal remedies) within 2 weeks before the first dose of study medication
- Positive Hepatitis A immunoglobulin M antibody (HAV IgM Ab), Hepatitis B surface antigen (HBsAg), Hepatitis C antibody (HCV Ab) or human immunodeficiency virus antibody (HIV Ab) at screening
- Donation or loss of blood of greater than 500 milliliters (mL) within 90 days prior to dosing
- Have participated in other clinical studies within 60 days prior to study randomization
Trial locations and contacts
2 sites in 1 country.
Singapore2 sites
Changi General Hospital; Clinical Trial & Research unit
Singapore, 529889
Study site
Singapore, 529889
About this study
Official title: A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO6864018 Following Oral Administration in Asian Healthy Subjects
This randomized, double-blind, placebo-controlled, single ascending dose study will assess the safety, pharmacokinetics, and pharmacodynamics of RO6864018 in healthy, male, Asian and Caucasian participants. Participants will be enrolled in cohorts and randomized 8:2 to receive a single oral administration of RO6864018 or placebo. Total study duration for each participant is up to 9 weeks.
- Conditions
- Healthy Volunteer
- Being tested
- RO6864018, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RO6864018Drug
A single oral ascending dose of RO6864018 capsules on Day 1.
PlaceboDrug
A single oral dose of placebo matching RO6864018 capsules on Day 1.
| Study group | Role | What they receive |
|---|---|---|
| RO6864018 | Experimental | Asian participants will receive a single oral dose of RO6864018 capsule on Day 1. The first dose escalation cohort will receive a single 400 mg oral dose. Dose will be escalated in subsequent cohorts (up to Cohort 4) up to a maximum of 1600 mg, based on safety, pharmacokinetic, and pharmacodynamic data available from lower dose cohorts. The Cohort 5 will include Caucasian participants who will receive a single 1200 mg (or the highest dose well-tolerated by Asian participants, if lower than 1200 mg) oral dose of RO6864018 capsules on Day 1. Receives: Drug: RO6864018 |
| Placebo | Placebo comparator | Participants will receive a single oral dose of placebo matching to RO6864018. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events
Measured: Baseline up to Day 29
Secondary outcomes (36)
Area Under the Plasma Concentration Time Curve From Time Zero to Infinity (AUC0-inf) of RO6864018
Measured: Pre-dose (0 hour), 0.25, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 18, 24, 36 and 48 hours post-Day 1 dose
AUC0-inf of Active Metabolite RO6871765
Measured: Pre-dose (0 hour), 0.25, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 18, 24, 36 and 48 hours post-Day 1 dose
AUC0-inf of Prodrug Metabolite RO6870868
Measured: Pre-dose (0 hour), 0.25, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 18, 24, 36 and 48 hours post-Day 1 dose
AUC0-inf of Minor Metabolite RO6872373
Measured: Pre-dose (0 hour), 0.25, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 18, 24, 36 and 48 hours post-Day 1 dose
Area Under the Plasma Concentration Time Curve From Time Zero to Last Measurable Concentration (AUClast) of RO6864018
Measured: Pre-dose (0 hour), 0.25, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 18, 24, 36 and 48 hours post-Day 1 dose
AUClast of Active Metabolite RO6871765
Measured: Pre-dose (0 hour), 0.25, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 18, 24, 36 and 48 hours post-Day 1 dose
AUClast of Prodrug Metabolite RO6870868
Measured: Pre-dose (0 hour), 0.25, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 18, 24, 36 and 48 hours post-Day 1 dose
AUClast of Minor Metabolite RO6872373
Measured: Pre-dose (0 hour), 0.25, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 18, 24, 36 and 48 hours post-Day 1 dose
Maximum Observed Plasma Concentration (Cmax) of RO6864018
Measured: Pre-dose (0 hour), 0.25, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 18, 24, 36 and 48 hours post-Day 1 dose
Cmax of Active Metabolite RO6871765
Measured: Pre-dose (0 hour), 0.25, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 18, 24, 36 and 48 hours post-Day 1 dose
Cmax of Prodrug Metabolite RO6870868
Measured: Pre-dose (0 hour), 0.25, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 18, 24, 36 and 48 hours post-Day 1 dose
Cmax of Minor Metabolite RO6872373
Measured: Pre-dose (0 hour), 0.25, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 18, 24, 36 and 48 hours post-Day 1 dose
Time to Maximum Plasma Concentration (Tmax) of RO6864018
Measured: Pre-dose (0 hour), 0.25, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 18, 24, 36 and 48 hours post-Day 1 dose
Tmax of Active Metabolite RO6871765
Measured: Pre-dose (0 hour), 0.25, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 18, 24, 36 and 48 hours post-Day 1 dose
Tmax of Minor Metabolite RO6872373
Measured: Pre-dose (0 hour), 0.25, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 18, 24, 36 and 48 hours post-Day 1 dose
RO6864018 Urine Concentration
Measured: Pre-dose (0-4 hours before dosing), 0-4, 4-8, 8-12, 12-24, 24-36, and 36-48 hours post-Day 1 dose
Active Metabolite RO6871765 Urine Concentration
Measured: Pre-dose (0-4 hours before dosing), 0-4, 4-8, 8-12, 12-24, 24-36, and 36-48 hours post-Day 1 dose
Prodrug Metabolite RO6870868 Urine Concentration
Measured: Pre-dose (0-4 hours before dosing), 0-4, 4-8, 8-12, 12-24, 24-36, and 36-48 hours post-Day 1 dose
Minor Metabolite RO6872373 Urine Concentration
Measured: Pre-dose (0-4 hours before dosing), 0-4, 4-8, 8-12, 12-24, 24-36, and 36-48 hours post-Day 1 dose
Apparent Terminal Elimination Half-Life (T1/2) of RO6864018
Measured: Pre-dose (0 hour), 0.25, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 18, 24, 36 and 48 hours post-Day 1 dose
T1/2 of Active Metabolite RO6871765
Measured: Pre-dose (0 hour), 0.25, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 18, 24, 36 and 48 hours post-Day 1 dose
T1/2 of Prodrug Metabolite RO6870868
Measured: Pre-dose (0 hour), 0.25, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 18, 24, 36 and 48 hours post-Day 1 dose
T1/2 of Minor Metabolite RO6872373
Measured: Pre-dose (0 hour), 0.25, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 18, 24, 36 and 48 hours post-Day 1 dose
Serum Interferon alpha Levels
Measured: Pre-dose (0 hours), 3, 6, 12, 18, 24, 36, and 48 hours post-Day 1 dose
Serum Interferon-Gamma-Inducible Protein-10 (IP-10) Levels
Measured: Pre-dose (0 hours), 3, 6, 12, 18, 24, 36, and 48 hours post-Day 1 dose
Serum Interleukin (IL)-6 Levels
Measured: Pre-dose (0 hours), 3, 6, 12, 18, 24, 36, and 48 hours post-Day 1 dose
Serum IL-10 Levels
Measured: Pre-dose (0 hours), 3, 6, 12, 18, 24, 36, and 48 hours post-Day 1 dose
Serum IL-12 Levels
Measured: Pre-dose (0 hours), 3, 6, 12, 18, 24, 36, and 48 hours post-Day 1 dose
Serum Neopterin Levels
Measured: Pre-dose (0 hours), 3, 6, 12, 18, 24, 36, and 48 hours post-Day 1 dose
Serum p40 (IL-12B) Levels
Measured: Pre-dose (0 hours), 3, 6, 12, 18, 24, 36, and 48 hours post-Day 1 dose
Interferon-Stimulated Gene-15 (ISG-15) Messenger Ribonucleic Acid (mRNA) Levels in Whole Blood
Measured: Pre-dose (0 hours), 3, 6, 12, 18, 24, 36, and 48 hours post-Day 1 dose
Myxovirus Resistance 1 (MX-1) Gene mRNA Levels in Whole Blood
Measured: Pre-dose (0 hours), 3, 6, 12, 18, 24, 36, and 48 hours post-Day 1 dose
Oligoadenylate Synthetase 1 (OAS 1) Gene mRNA Levels in Whole Blood
Measured: Pre-dose (0 hours), 3, 6, 12, 18, 24, 36, and 48 hours post-Day 1 dose
Toll-Like Receptor 7 (TLR7) Gene mRNA Levels in Whole Blood
Measured: Pre-dose (0 hours), 3, 6, 12, 18, 24, 36, and 48 hours post-Day 1 dose
Tmax of Prodrug Metabolite RO6870868
Measured: Pre-dose (0 hour), 0.25, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 18, 24, 36 and 48 hours post-Day 1 dose
Serum Tumor Necrosis Factor Alpha Levels
Measured: Pre-dose (0 hours), 3, 6, 12, 18, 24, 36, and 48 hours post-Day 1 dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2013 (estimated)
- Study startDec 2013
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 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
- NCT02015715
- Sponsor's protocol ID
- YP29017
- Status last verified
- Feb 2017
- First submitted
- 28 Nov 2013
- Last updated
- 1 Mar 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO6864018 Following Oral Administration in Asian Healthy Subjects
- ClinicalTrials.gov ID
- NCT02015715
- Acronym / sponsor ID
- YP29017
- Conditions
- Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Dec 2013
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 19 Dec 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 randomized, double-blind, placebo-controlled, single ascending dose study will assess the safety, pharmacokinetics, and pharmacodynamics of RO6864018 in healthy, male, Asian and Caucasian participants. Participants will be enrolled in cohorts and randomized 8:2 to receive a single oral administration of RO6864018 or placebo. Total study duration for each participant is up to 9 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RO6864018 | Experimental | Drug: RO6864018Asian participants will receive a single oral dose of RO6864018 capsule on Day 1. The first dose escalation cohort will receive a single 400 mg oral dose. Dose will be escalated in subsequent cohorts (up to Cohort 4) up to a maximum of 1600 mg, based on safety, pharmacokinetic, and pharmacodynamic data available from lower dose cohorts. The Cohort 5 will include Caucasian participants who will receive a single 1200 mg (or the highest dose well-tolerated by Asian participants, if lower than 1200 mg) oral dose of RO6864018 capsules on Day 1. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive a single oral dose of placebo matching to RO6864018. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy male participants of ethnic Chinese, Korean, Japanese origin or Caucasian
- No signs of any active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead electrocardiogram (ECG), hematology, blood chemistry, serology and urinalysis
- Body Mass Index (BMI) between 18 to 30 kilograms per square meter (kg/m^2) inclusive, and a weight range of 50 to 100 kilograms (kg) (110 to 220 pounds [lb]) inclusive at screening
- Non-smokers, or use of less than (<) 10 cigarettes (or equivalent nicotine-containing product) per day
Key exclusion criteria (11 listed)
- History or symptoms of any significant disease
- Personal or family history of congenital long QT syndrome or sudden death
- Any confirmed significant allergic reactions against any drug, or multiple drug allergies (non-active hay fever is acceptable)
- Positive results for anti-nuclear antibody (ANA), anti-mitochondrial antibody (AMA), anti-smooth muscle antibody (ASMA) and thyroid peroxidase antibody
- Suspicion of regular consumption of drug of abuse
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 |
|---|---|---|
| RO6864018A single oral ascending dose of RO6864018 capsules on Day 1. | Drug | RO6864018 |
| PlaceboA single oral dose of placebo matching RO6864018 capsules on Day 1. | Drug | Placebo |
Primary outcome
Number of Participants With Adverse Events
Time frame: Baseline up to Day 29
36 secondary outcomes
Area Under the Plasma Concentration Time Curve From Time Zero to Infinity (AUC0-inf) of RO6864018
Time frame: Pre-dose (0 hour), 0.25, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 18, 24, 36 and 48 hours post-Day 1 dose
AUC0-inf of Active Metabolite RO6871765
Time frame: Pre-dose (0 hour), 0.25, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 18, 24, 36 and 48 hours post-Day 1 dose
AUC0-inf of Prodrug Metabolite RO6870868
Time frame: Pre-dose (0 hour), 0.25, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 18, 24, 36 and 48 hours post-Day 1 dose
AUC0-inf of Minor Metabolite RO6872373
Time frame: Pre-dose (0 hour), 0.25, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 18, 24, 36 and 48 hours post-Day 1 dose
Area Under the Plasma Concentration Time Curve From Time Zero to Last Measurable Concentration (AUClast) of RO6864018
Time frame: Pre-dose (0 hour), 0.25, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 18, 24, 36 and 48 hours post-Day 1 dose
AUClast of Active Metabolite RO6871765
Time frame: Pre-dose (0 hour), 0.25, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 18, 24, 36 and 48 hours post-Day 1 dose
AUClast of Prodrug Metabolite RO6870868
Time frame: Pre-dose (0 hour), 0.25, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 18, 24, 36 and 48 hours post-Day 1 dose
AUClast of Minor Metabolite RO6872373
Time frame: Pre-dose (0 hour), 0.25, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 18, 24, 36 and 48 hours post-Day 1 dose
Maximum Observed Plasma Concentration (Cmax) of RO6864018
Time frame: Pre-dose (0 hour), 0.25, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 18, 24, 36 and 48 hours post-Day 1 dose
Cmax of Active Metabolite RO6871765
Time frame: Pre-dose (0 hour), 0.25, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 18, 24, 36 and 48 hours post-Day 1 dose
Cmax of Prodrug Metabolite RO6870868
Time frame: Pre-dose (0 hour), 0.25, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 18, 24, 36 and 48 hours post-Day 1 dose
Cmax of Minor Metabolite RO6872373
Time frame: Pre-dose (0 hour), 0.25, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 18, 24, 36 and 48 hours post-Day 1 dose
Time to Maximum Plasma Concentration (Tmax) of RO6864018
Time frame: Pre-dose (0 hour), 0.25, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 18, 24, 36 and 48 hours post-Day 1 dose
Tmax of Active Metabolite RO6871765
Time frame: Pre-dose (0 hour), 0.25, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 18, 24, 36 and 48 hours post-Day 1 dose
Tmax of Minor Metabolite RO6872373
Time frame: Pre-dose (0 hour), 0.25, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 18, 24, 36 and 48 hours post-Day 1 dose
RO6864018 Urine Concentration
Time frame: Pre-dose (0-4 hours before dosing), 0-4, 4-8, 8-12, 12-24, 24-36, and 36-48 hours post-Day 1 dose
Active Metabolite RO6871765 Urine Concentration
Time frame: Pre-dose (0-4 hours before dosing), 0-4, 4-8, 8-12, 12-24, 24-36, and 36-48 hours post-Day 1 dose
Prodrug Metabolite RO6870868 Urine Concentration
Time frame: Pre-dose (0-4 hours before dosing), 0-4, 4-8, 8-12, 12-24, 24-36, and 36-48 hours post-Day 1 dose
Minor Metabolite RO6872373 Urine Concentration
Time frame: Pre-dose (0-4 hours before dosing), 0-4, 4-8, 8-12, 12-24, 24-36, and 36-48 hours post-Day 1 dose
Apparent Terminal Elimination Half-Life (T1/2) of RO6864018
Time frame: Pre-dose (0 hour), 0.25, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 18, 24, 36 and 48 hours post-Day 1 dose
T1/2 of Active Metabolite RO6871765
Time frame: Pre-dose (0 hour), 0.25, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 18, 24, 36 and 48 hours post-Day 1 dose
T1/2 of Prodrug Metabolite RO6870868
Time frame: Pre-dose (0 hour), 0.25, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 18, 24, 36 and 48 hours post-Day 1 dose
T1/2 of Minor Metabolite RO6872373
Time frame: Pre-dose (0 hour), 0.25, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 18, 24, 36 and 48 hours post-Day 1 dose
Serum Interferon alpha Levels
Time frame: Pre-dose (0 hours), 3, 6, 12, 18, 24, 36, and 48 hours post-Day 1 dose
Serum Interferon-Gamma-Inducible Protein-10 (IP-10) Levels
Time frame: Pre-dose (0 hours), 3, 6, 12, 18, 24, 36, and 48 hours post-Day 1 dose
Serum Interleukin (IL)-6 Levels
Time frame: Pre-dose (0 hours), 3, 6, 12, 18, 24, 36, and 48 hours post-Day 1 dose
Serum IL-10 Levels
Time frame: Pre-dose (0 hours), 3, 6, 12, 18, 24, 36, and 48 hours post-Day 1 dose
Serum IL-12 Levels
Time frame: Pre-dose (0 hours), 3, 6, 12, 18, 24, 36, and 48 hours post-Day 1 dose
Serum Neopterin Levels
Time frame: Pre-dose (0 hours), 3, 6, 12, 18, 24, 36, and 48 hours post-Day 1 dose
Serum p40 (IL-12B) Levels
Time frame: Pre-dose (0 hours), 3, 6, 12, 18, 24, 36, and 48 hours post-Day 1 dose
Interferon-Stimulated Gene-15 (ISG-15) Messenger Ribonucleic Acid (mRNA) Levels in Whole Blood
Time frame: Pre-dose (0 hours), 3, 6, 12, 18, 24, 36, and 48 hours post-Day 1 dose
Myxovirus Resistance 1 (MX-1) Gene mRNA Levels in Whole Blood
Time frame: Pre-dose (0 hours), 3, 6, 12, 18, 24, 36, and 48 hours post-Day 1 dose
Oligoadenylate Synthetase 1 (OAS 1) Gene mRNA Levels in Whole Blood
Time frame: Pre-dose (0 hours), 3, 6, 12, 18, 24, 36, and 48 hours post-Day 1 dose
Toll-Like Receptor 7 (TLR7) Gene mRNA Levels in Whole Blood
Time frame: Pre-dose (0 hours), 3, 6, 12, 18, 24, 36, and 48 hours post-Day 1 dose
Tmax of Prodrug Metabolite RO6870868
Time frame: Pre-dose (0 hour), 0.25, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 18, 24, 36 and 48 hours post-Day 1 dose
Serum Tumor Necrosis Factor Alpha Levels
Time frame: Pre-dose (0 hours), 3, 6, 12, 18, 24, 36, and 48 hours post-Day 1 dose
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 1 Mar 2017.
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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-La Roche
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RO6864018 in people with Healthy Volunteer, run by Hoffmann-La Roche at 2 sites in Singapore.
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 11 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 1 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Singapore. 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?
Number of Participants With Adverse Events (time frame: Baseline up to Day 29). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Mar 2017.