Healthy VolunteerPhase 1NCT02699372
The Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of RO6889450 in Healthy Volunteers
A Phase 1 study testing RO6889450 in people with Healthy Volunteer, run by Hoffmann-La Roche at 1 site in Netherlands.
Trial summary
This randomized, single center, adaptive single ascending dose (Part 1) and multiple ascending dose (Part 2) study is designed to assess the safety, tolerability, pharmacokinetic, and pharmacodynamics following an oral administration of RO6889450 versus placebo in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- RO6889450
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 164 participants
- Where
- 1 siteNetherlands
- Study dates
- 21 Mar 2016to 14 Apr 2017
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- A body mass index (BMI) between 18 to 30 kilogram per square meter (kg/m^2) inclusive
- Body weight in the range of 50 to 100 kilogram (kg) and right-handed - Part 2 only
- For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods
- For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm
- Fluent in the language of the Investigator and study staff (including raters)
- Able to participate and comply with the study restrictions
Who cannot join
- Part 1 and Part 2:
- Disorders of the central nervous system (CNS), psychiatric disorders, behavioral disturbances
- Participants who, in the Investigator's judgment, pose a suicidal or homicidal risk
- Any personal or familial history (first degree) of seizures, epilepsy or other convulsive condition
- Positive family history of psychosis or mood disorders up to first degree relative
- Angle closure glaucoma, history or current significant ophthalmologic or neurologic condition that would adversely affect the pupillometry assessment
Show all 18Show fewer
- Suspicion of regular consumption of drug of abuse and/or any history of alcohol addiction with positive urine drug screen and/or positive alcohol urine test, or regular smoker
- Positive result on hepatitis B (HBV), hepatitis C (HCV), or human immunodeficiency virus antibody (HIV 1 and 2)
- Any prescribed or OTC medications (including vitamins or herbal remedies) taken within 4 weeks prior to first dosing or within 5 times the elimination half-life of the medication prior to first dosing (whichever is longer)
- Taking any nutrients known to modulate CYP3A activity (e.g., grapefruit juice; Seville orange) within 2 weeks prior to administration of study drugs
- Clinically significant abnormalities in laboratory test results (including hepatic and renal panels, complete blood count, chemistry panel and urinalysis)
- Participation in an investigational drug or device study within 90 days prior to screening
- Dietary restrictions that would prohibit the consumption of standardized meals
- Concomitant disease or condition that could interfere with, or treatment of which might interfere with, the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the participant in this study
- Part 2:
- Contraindications for magnetic resonance imaging (MRI) scans or any brain/head abnormalities restricting MRI eligibility. Any sensorial impairment such as deafness and reduced visual acuity which cannot be corrected in the fMRI scanner
- Use of any psychoactive medication, or medications known to have effects on CNS or blood flow taken within 4 weeks prior to first dosing or within 5 times the elimination half-life of the medication prior to first dosing (whichever is longer)
- Fulfilment of any of the MRI contraindications on the standard radiography screening questionnaire
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
PRA Health Sciences Early Development Services
Zuidlaren, 9471 GP
About this study
Official title: A Single-center, Randomized, Investigator/Subject-Blind, Adaptive Single-ascending Dose (Part 1) and Multiple Ascending Dose (Part 2), Placebo-Controlled, Parallel Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO6889450 Following Oral Administration in Healthy Subjects
This randomized, single center, adaptive single ascending dose (Part 1) and multiple ascending dose (Part 2) study is designed to assess the safety, tolerability, pharmacokinetic, and pharmacodynamics following an oral administration of RO6889450 versus placebo in healthy volunteers. The anticipated duration of this study is approximately 18 weeks.
- Conditions
- Healthy Volunteer
- Being tested
- Placebo, RO6889450
- Keywords
- Healthy Volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
RO6889450Drug
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Healthy volunteers will receive the placebo equivalent to RO6889450 as oral capsules. Receives: Drug: Placebo |
| RO6889450: Part 1 Single Ascending Dose (SAD) | Experimental | Participants will undergo a series of screening visits prior to treatment and 4 weeks follow-up. Healthy volunteers will be enrolled in up to 7 dose groups (5 milligram [mg] to 450 mg) and will receive single oral dose of RO6889450 in the morning of the Day 1. Receives: Drug: RO6889450 |
| RO6889450: Part 2 Multiple Ascending Dose (MAD) | Experimental | The starting dose for Part 2 MAD will be determined by analysis of safety and pharmacokinetic data of Part 1 SAD. All participants will receive RO6889450 orally for 14 days. Receives: Drug: RO6889450 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Dose Limiting Toxicities After Single Ascending Dose (SAD) - Part 1
Measured: up to 22 days
Area Under the Curve from Time Zero to end of dosing interval (AUCtau) After Multiple Oral Ascending Doses - Part 2
Measured: Part 2: predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 hr postdose on Day 1; predose on Days 2, 3, 4, 5, 6, 7, 8, 10, 12, 13, predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 hr postdose on Day 14, Days 15, 16, 17, 19, 20, 21
Percentage of Participants With Dose Limiting Toxicities After Multiple Oral Ascending Doses (MAD) - Part 2
Measured: up to 35 days
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 to inf)] After Single Ascending Dose - Part 1
Measured: Part 1: predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 hours (hr) postdose on Day 1; Day 2, 3, 4, 6, 7, 8
RO6889450 Maximum Plasma Concentration (Cmax) After Single Oral Ascending Doses
Measured: Part 1: predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 hours postdose on Day 1, Days 2, 3, 4, 6, 7, 8
RO6889450 Maximum Plasma Concentration (Cmax) After Multiple Oral Ascending Doses
Measured: Part 2: predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 hours postdose on Day 1, predose on Days 2, 3, 4, 5, 6, 7, 8, 10, 12, 13, predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 hours postdose on Day 14, Days 15, 16, 17, 19, 20, 21
RO6889450 Minimum Observed Plasma Trough Concentration (Cmin)
Measured: Part 2: predose on Days 2, 3, 4, 5, 6, 7, 8, 10, 12, 13, predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 hours postdose on Day 14, Days 15
Secondary outcomes (40)
Time to Reach Maximum Observed Plasma Concentration (Tmax) After Multiple Ascending Dose - Part 2
Measured: predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 hr postdose, Days 2, 3, 4, 5, 6, 7, 8, 10, 12, 13, predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 hr postdose on Day 14, Days 15, 16, 17, 19, 20, 21
Terminal Rate Constant After Multiple Ascending Dose - Part 2
Measured: Part 2: predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 hr postdose on Day 1, predose on Days 2, 3, 4, 5, 6, 7, 8, 10, 12, 13, predose, 0.5,1,1.5, 2, 2.5, 3,4, 6, 8, 12, 16 hr postdose on Day 14, Days 15, 16, 17, 19, 20, 21
Apparent Terminal Half-Life (t1/2) After Multiple Ascending Dose - Part 2
Measured: Part 2: predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 hr postdose on Day 1, predose on Days 2, 3, 4, 5, 6, 7, 8, 10, 12, 13, predose, 0.5, 1, 1.5, 2, 2.5, 3,4, 6, 8, 12, 16 hr postdose on Day 14, Days 15, 16, 17, 19, 20, 21
Apparent Oral Clearance (CL/F) After Multiple Ascending Dose - Part 2
Measured: Part 2: predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 hr postdose on Day 1, predose on Days 2, 3, 4, 5, 6, 7, 8, 10, 12, 13, predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 hr postdose on Day 14, Days 15, 16, 17, 19, 20, 21
Cumulative Amount Excreted Unchanged in Urine (Ae) After Multiple Ascending Dose - Part 2
Measured: Part 2: predose, 0 to 6, 6 to 12, 12 to 24 hours postdose on Day 1, 14, 24 to 48 and 48 to 72 hours after Day 14 dosing
Renal Clearance (CLR) After Multiple Ascending Dose - Part 2
Measured: Part 2: predose, 0 to 6, 6 to 12, 12 to 24 hours postdose on Day 1, 14, 24 to 48 and 48 to 72 hours after Day 14 dosing
Fasting Glucose Concentrations After Multiple Ascending Dose - Part 2
Measured: Part 2: Baseline, Days 7, 15, 17
Plasma Concentration of Prolactin - Part 2
Measured: Part 2: Day 1, 14, 15
Scotopic Pupil Diameter as Assessed by Pupillometer - Part 2
Measured: Part 2: Day 1, 2, 14, 15
Time to Reach Maximum Observed Plasma Concentration (Tmax) After Single Ascending Dose - Part 1
Measured: Part 1: predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 hours (hr) postdose on Day 1, Days 2, 3, 4, 6, 7, 8
Last Measurable Concentration (Clast) After Single Ascending Dose - Part 1
Measured: Part 1: predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 hours postdose on Day 1, Days 2, 3, 4, 6, 7, 8
Time to Last Measurable Concentration (Tlast) After Single Ascending Dose - Part 1
Measured: Part 1: predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 hours postdose on Day 1, Days 2, 3, 4, 6, 7, 8
Terminal Rate Constant After Single Ascending Dose - Part 1
Measured: Part 1: predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 hr postdose on Day 1, Days 2, 3, 4, 6, 7, 8
Apparent Terminal Half-Life (t1/2) After Single Ascending Dose - Part 1
Measured: Part 1: predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 hr postdose on Day 1, Days 2, 3, 4, 6, 7, 8
Area Under the Plasma Concentration Versus Time Curve From Zero to 24 Hours Post-Dose (AUC0-24h) After Single Ascending Dose - Part 1
Measured: Part 1: predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 hours postdose on Day 1, Days 2, 3, 4, 6, 7, 8
Area Under the Plasma Concentration Versus Time Curve up to the Last Measurable Concentration (AUC0-last) After Single Ascending Dose - Part 1
Measured: Part 1: predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 hours postdose on Day 1, Days 2, 3, 4, 6, 7, 8
Apparent Oral Clearance (CL/F) After Single Ascending Dose - Part 1
Measured: Part 1: predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 hr postdose on Day 1, Days 2, 3, 4, 6, 7, 8
Cumulative Amount Excreted Unchanged in the Urine (Ae) After Single Ascending Dose - Part 1
Measured: Part 1: predose, 0 to 6, 6 to 12, 12 to 24 hours postdose on Day 1, 24 to 48, 48 to 72 hours after Day 1 dosing
Renal Clearance (CLR) After Single Ascending Dose - Part 1
Measured: Part 1: predose, 0 to 6, 6 to 12, 12 to 24 hours postdose on Day 1, 24 to 48, 48 to 72 hours after Day 1 dosing
Accumulation Ratio for AUCtau (RAUC), Calculated as Day 14 AUC0-tau/Day 1 AUC0-tau - Part 2
Measured: predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 hours (hr) postdose on Day 1; predose, 0.5,1,1.5, 2, 2.5, 3,4, 6, 8, 12, 16, 24 hr postdose on Day 14
Accumulation Ratio for Cmax (RCmax), Calculated as Day 14 Cmax / Day 1 Cmax - Part 2
Measured: predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 hours (hr) postdose on Day 1; predose, 0.5,1,1.5, 2, 2.5, 3,4, 6, 8, 12, 16, 24 hr postdose on Day 14
Accumulation Ratio for Ctrough RCtrough, Calculated as Day 14 Ctrough / Day 1 Ctrough - Part 2
Measured: predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 hours (hr) postdose on Day 1; predose, 0.5,1,1.5, 2, 2.5, 3,4, 6, 8, 12, 16, 24 hr postdose on Day 14
Fasting Glucose Concentrations After Single - Part 1
Measured: Part 1: Baseline, Day 4
Change From Baseline in Glucose Level at Day 14 - Part 2
Measured: Baseline, Day 14
Change From Baseline in Insulin Level at Day 14 - Part 2
Measured: Baseline, Day 14
Change From Baseline in C-peptide Level at Day 14 - Part 2
Measured: Baseline, Day 14
Change From Baseline in Gastric Inhibitory Polypeptide (GIP) Level at Day 14 - Part 2
Measured: Baseline, Day 14
Change From Baseline in Glucagon-like Peptide-1 (GLP-1) Level at Day 14 - Part 2
Measured: Baseline, Day 14
Columbia Suicide-Severity Rating Scale (C-SSRS) Scores - Part 1
Measured: Part 1: Day 4
Columbia Suicide-Severity Rating Scale (C-SSRS) Scores - Part 2
Measured: Part 2: Day 15
Capillary Blood Glucose Levels - Part 1
Measured: Part 1: Baseline through Day 4
Capillary Blood Glucose Levels - Part 2
Measured: Part 2: Baseline through Day 17
Urine Concentration of Dopamine Metabolite - Part 2
Measured: Baseline, Day 12, Day 13
Plasma Concentration of Prolactin - Part 1
Measured: Part 1: Day 1, Day 2
Change From Baseline in Body Weight at Days 7 and 15 - Part 2
Measured: Baseline, Day 7, 15
Addiction Research Center Inventory (ARCI-49) Questionnaire Score - Part 2
Measured: Baseline, Day 1, 7, 14
Scotopic Pupil Diameter as Assessed by Pupillometer - Part 1
Measured: Part 1: Day 1, 2
Change From Baseline in Regional Cerebral Blood Flow (CBF), as Assessed by Functional Magnetic Resonance Imaging (fMRI) at Days 7 or 8, 12 or 13
Measured: Baseline, Day 7 or 8, 12 or 13
Facial Expression Recognition Task (FERT) Score, as Assessed by Emotional Test Battery (ETB) - Part 2
Measured: Baseline, Day 12 or 13
Reward Learning Task Score, as Assessed by Effort-Based Paradigms - Part 2
Measured: Baseline, Day 12 or 13
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2016 (estimated)
- Study start21 Mar 2016
- Primary completion14 Apr 2017
- Study completion14 Apr 2017
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 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
- 164 participants (estimated)
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
- NCT02699372
- Sponsor's protocol ID
- BP30134
- Other IDs
- 2015-005509-35, 2015
- Status last verified
- Nov 2017
- First submitted
- 23 Feb 2016
- Last updated
- 24 Nov 2017
- Results posted
- No
Publications
Fournier C, Buchy D, Mohr S, Pahler A, Jacobsen B, Norcross R, Pflieger P, Sewing S, Greiter-Wilke A, Kuennecke B, Schmitt C, Morrison M, Marchesi M, Holiga S, Gerlach I, Hoener MC. Novel selective morpholine trace amine-associated receptor 1 partial agonists show promising preclinical effects for neuropsychiatric disorders and are well tolerated in healthy volunteers. Mol Psychiatry. 2026 Jun;31(6):3188-3198. doi: 10.1038/s41380-026-03465-y. Epub 2026 Feb 4.
PubMed 41639230
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Randomized, Investigator/Subject-Blind, Adaptive Single-ascending Dose (Part 1) and Multiple Ascending Dose (Part 2), Placebo-Controlled, Parallel Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO6889450 Following Oral Administration in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02699372
- Acronym / sponsor ID
- BP30134
- Conditions
- Healthy Volunteer
- Keywords
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 164 participants (estimated)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 21 Mar 2016 (actual)
- Primary completion
- 14 Apr 2017 (actual)
- Study completion
- 14 Apr 2017 (actual)
- First posted
- 4 Mar 2016 (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, single center, adaptive single ascending dose (Part 1) and multiple ascending dose (Part 2) study is designed to assess the safety, tolerability, pharmacokinetic, and pharmacodynamics following an oral administration of RO6889450 versus placebo in healthy volunteers. The anticipated duration of this study is approximately 18 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboHealthy volunteers will receive the placebo equivalent to RO6889450 as oral capsules. |
| RO6889450: Part 1 Single Ascending Dose (SAD) | Experimental | Drug: RO6889450Participants will undergo a series of screening visits prior to treatment and 4 weeks follow-up. Healthy volunteers will be enrolled in up to 7 dose groups (5 milligram [mg] to 450 mg) and will receive single oral dose of RO6889450 in the morning of the Day 1. |
| RO6889450: Part 2 Multiple Ascending Dose (MAD) | Experimental | Drug: RO6889450The starting dose for Part 2 MAD will be determined by analysis of safety and pharmacokinetic data of Part 1 SAD. All participants will receive RO6889450 orally for 14 days. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- A body mass index (BMI) between 18 to 30 kilogram per square meter (kg/m^2) inclusive
- Body weight in the range of 50 to 100 kilogram (kg) and right-handed - Part 2 only
- For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods
- For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm
- Fluent in the language of the Investigator and study staff (including raters)
Key exclusion criteria (18 listed)
- Disorders of the central nervous system (CNS), psychiatric disorders, behavioral disturbances
- Participants who, in the Investigator's judgment, pose a suicidal or homicidal risk
- Any personal or familial history (first degree) of seizures, epilepsy or other convulsive condition
- Positive family history of psychosis or mood disorders up to first degree relative
- Angle closure glaucoma, history or current significant ophthalmologic or neurologic condition that would adversely affect the pupillometry assessment
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 |
|---|---|---|
| Placebo | Drug | Placebo |
| RO6889450 | Drug | RO6889450: Part 1 Single Ascending Dose (SAD), RO6889450: Part 2 Multiple Ascending Dose (MAD) |
Primary outcome
Percentage of Participants With Dose Limiting Toxicities After Single Ascending Dose (SAD) - Part 1
Time frame: up to 22 days
Area Under the Curve from Time Zero to end of dosing interval (AUCtau) After Multiple Oral Ascending Doses - Part 2
Time frame: Part 2: predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 hr postdose on Day 1; predose on Days 2, 3, 4, 5, 6, 7, 8, 10, 12, 13, predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 hr postdose on Day 14, Days 15, 16, 17, 19, 20, 21
Percentage of Participants With Dose Limiting Toxicities After Multiple Oral Ascending Doses (MAD) - Part 2
Time frame: up to 35 days
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 to inf)] After Single Ascending Dose - Part 1
Time frame: Part 1: predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 hours (hr) postdose on Day 1; Day 2, 3, 4, 6, 7, 8
RO6889450 Maximum Plasma Concentration (Cmax) After Single Oral Ascending Doses
Time frame: Part 1: predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 hours postdose on Day 1, Days 2, 3, 4, 6, 7, 8
RO6889450 Maximum Plasma Concentration (Cmax) After Multiple Oral Ascending Doses
Time frame: Part 2: predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 hours postdose on Day 1, predose on Days 2, 3, 4, 5, 6, 7, 8, 10, 12, 13, predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 hours postdose on Day 14, Days 15, 16, 17, 19, 20, 21
RO6889450 Minimum Observed Plasma Trough Concentration (Cmin)
Time frame: Part 2: predose on Days 2, 3, 4, 5, 6, 7, 8, 10, 12, 13, predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 hours postdose on Day 14, Days 15
40 secondary outcomes
Time to Reach Maximum Observed Plasma Concentration (Tmax) After Multiple Ascending Dose - Part 2
Time frame: predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 hr postdose, Days 2, 3, 4, 5, 6, 7, 8, 10, 12, 13, predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 hr postdose on Day 14, Days 15, 16, 17, 19, 20, 21
Terminal Rate Constant After Multiple Ascending Dose - Part 2
Time frame: Part 2: predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 hr postdose on Day 1, predose on Days 2, 3, 4, 5, 6, 7, 8, 10, 12, 13, predose, 0.5,1,1.5, 2, 2.5, 3,4, 6, 8, 12, 16 hr postdose on Day 14, Days 15, 16, 17, 19, 20, 21
Apparent Terminal Half-Life (t1/2) After Multiple Ascending Dose - Part 2
Time frame: Part 2: predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 hr postdose on Day 1, predose on Days 2, 3, 4, 5, 6, 7, 8, 10, 12, 13, predose, 0.5, 1, 1.5, 2, 2.5, 3,4, 6, 8, 12, 16 hr postdose on Day 14, Days 15, 16, 17, 19, 20, 21
Apparent Oral Clearance (CL/F) After Multiple Ascending Dose - Part 2
Time frame: Part 2: predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 hr postdose on Day 1, predose on Days 2, 3, 4, 5, 6, 7, 8, 10, 12, 13, predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 hr postdose on Day 14, Days 15, 16, 17, 19, 20, 21
Cumulative Amount Excreted Unchanged in Urine (Ae) After Multiple Ascending Dose - Part 2
Time frame: Part 2: predose, 0 to 6, 6 to 12, 12 to 24 hours postdose on Day 1, 14, 24 to 48 and 48 to 72 hours after Day 14 dosing
Renal Clearance (CLR) After Multiple Ascending Dose - Part 2
Time frame: Part 2: predose, 0 to 6, 6 to 12, 12 to 24 hours postdose on Day 1, 14, 24 to 48 and 48 to 72 hours after Day 14 dosing
Fasting Glucose Concentrations After Multiple Ascending Dose - Part 2
Time frame: Part 2: Baseline, Days 7, 15, 17
Plasma Concentration of Prolactin - Part 2
Time frame: Part 2: Day 1, 14, 15
Scotopic Pupil Diameter as Assessed by Pupillometer - Part 2
Time frame: Part 2: Day 1, 2, 14, 15
Time to Reach Maximum Observed Plasma Concentration (Tmax) After Single Ascending Dose - Part 1
Time frame: Part 1: predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 hours (hr) postdose on Day 1, Days 2, 3, 4, 6, 7, 8
Last Measurable Concentration (Clast) After Single Ascending Dose - Part 1
Time frame: Part 1: predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 hours postdose on Day 1, Days 2, 3, 4, 6, 7, 8
Time to Last Measurable Concentration (Tlast) After Single Ascending Dose - Part 1
Time frame: Part 1: predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 hours postdose on Day 1, Days 2, 3, 4, 6, 7, 8
Terminal Rate Constant After Single Ascending Dose - Part 1
Time frame: Part 1: predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 hr postdose on Day 1, Days 2, 3, 4, 6, 7, 8
Apparent Terminal Half-Life (t1/2) After Single Ascending Dose - Part 1
Time frame: Part 1: predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 hr postdose on Day 1, Days 2, 3, 4, 6, 7, 8
Area Under the Plasma Concentration Versus Time Curve From Zero to 24 Hours Post-Dose (AUC0-24h) After Single Ascending Dose - Part 1
Time frame: Part 1: predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 hours postdose on Day 1, Days 2, 3, 4, 6, 7, 8
Area Under the Plasma Concentration Versus Time Curve up to the Last Measurable Concentration (AUC0-last) After Single Ascending Dose - Part 1
Time frame: Part 1: predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 hours postdose on Day 1, Days 2, 3, 4, 6, 7, 8
Apparent Oral Clearance (CL/F) After Single Ascending Dose - Part 1
Time frame: Part 1: predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 hr postdose on Day 1, Days 2, 3, 4, 6, 7, 8
Cumulative Amount Excreted Unchanged in the Urine (Ae) After Single Ascending Dose - Part 1
Time frame: Part 1: predose, 0 to 6, 6 to 12, 12 to 24 hours postdose on Day 1, 24 to 48, 48 to 72 hours after Day 1 dosing
Renal Clearance (CLR) After Single Ascending Dose - Part 1
Time frame: Part 1: predose, 0 to 6, 6 to 12, 12 to 24 hours postdose on Day 1, 24 to 48, 48 to 72 hours after Day 1 dosing
Accumulation Ratio for AUCtau (RAUC), Calculated as Day 14 AUC0-tau/Day 1 AUC0-tau - Part 2
Time frame: predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 hours (hr) postdose on Day 1; predose, 0.5,1,1.5, 2, 2.5, 3,4, 6, 8, 12, 16, 24 hr postdose on Day 14
Accumulation Ratio for Cmax (RCmax), Calculated as Day 14 Cmax / Day 1 Cmax - Part 2
Time frame: predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 hours (hr) postdose on Day 1; predose, 0.5,1,1.5, 2, 2.5, 3,4, 6, 8, 12, 16, 24 hr postdose on Day 14
Accumulation Ratio for Ctrough RCtrough, Calculated as Day 14 Ctrough / Day 1 Ctrough - Part 2
Time frame: predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 hours (hr) postdose on Day 1; predose, 0.5,1,1.5, 2, 2.5, 3,4, 6, 8, 12, 16, 24 hr postdose on Day 14
Fasting Glucose Concentrations After Single - Part 1
Time frame: Part 1: Baseline, Day 4
Change From Baseline in Glucose Level at Day 14 - Part 2
Time frame: Baseline, Day 14
Change From Baseline in Insulin Level at Day 14 - Part 2
Time frame: Baseline, Day 14
Change From Baseline in C-peptide Level at Day 14 - Part 2
Time frame: Baseline, Day 14
Change From Baseline in Gastric Inhibitory Polypeptide (GIP) Level at Day 14 - Part 2
Time frame: Baseline, Day 14
Change From Baseline in Glucagon-like Peptide-1 (GLP-1) Level at Day 14 - Part 2
Time frame: Baseline, Day 14
Columbia Suicide-Severity Rating Scale (C-SSRS) Scores - Part 1
Time frame: Part 1: Day 4
Columbia Suicide-Severity Rating Scale (C-SSRS) Scores - Part 2
Time frame: Part 2: Day 15
Capillary Blood Glucose Levels - Part 1
Time frame: Part 1: Baseline through Day 4
Capillary Blood Glucose Levels - Part 2
Time frame: Part 2: Baseline through Day 17
Urine Concentration of Dopamine Metabolite - Part 2
Time frame: Baseline, Day 12, Day 13
Plasma Concentration of Prolactin - Part 1
Time frame: Part 1: Day 1, Day 2
Change From Baseline in Body Weight at Days 7 and 15 - Part 2
Time frame: Baseline, Day 7, 15
Addiction Research Center Inventory (ARCI-49) Questionnaire Score - Part 2
Time frame: Baseline, Day 1, 7, 14
Scotopic Pupil Diameter as Assessed by Pupillometer - Part 1
Time frame: Part 1: Day 1, 2
Change From Baseline in Regional Cerebral Blood Flow (CBF), as Assessed by Functional Magnetic Resonance Imaging (fMRI) at Days 7 or 8, 12 or 13
Time frame: Baseline, Day 7 or 8, 12 or 13
Facial Expression Recognition Task (FERT) Score, as Assessed by Emotional Test Battery (ETB) - Part 2
Time frame: Baseline, Day 12 or 13
Reward Learning Task Score, as Assessed by Effort-Based Paradigms - Part 2
Time frame: Baseline, Day 12 or 13
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 24 Nov 2017.
- Derived from this study: PubMed 41639230Fournier C, Buchy D, Mohr S, Pahler A, Jacobsen B, Norcross R, Pflieger P, Sewing S, Greiter-Wilke A, Kuennecke B, Schmitt C, Morrison M, Marchesi M, Holiga S, Gerlach I, Hoener MC. Novel selective morpholine trace amine-associated receptor 1 partial agonists show promising preclinical effects for neuropsychiatric disorders and are well tolerated in healthy volunteers. Mol Psychiatry. 2026 Jun;31(6):3188-3198. doi: 10.1038/s41380-026-03465-y. Epub 2026 Feb 4.
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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
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 RO6889450 in people with Healthy Volunteer, run by Hoffmann-La Roche at 1 site in Netherlands.
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 6 inclusion and 18 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 24 Nov 2017. 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 Netherlands. 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?
Percentage of Participants With Dose Limiting Toxicities After Single Ascending Dose (SAD) - Part 1 (time frame: up to 22 days). 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 NCT02699372, 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 24 Nov 2017.