Healthy ParticipantsPhase 1NCT03236844
Relative Bioavailability of Gantenerumab Produced by G4 Process Versus G3 Process Following Subcutaneous (SC) Injection in Healthy Participants
A Phase 1 study testing Gantenerumab in people with Healthy Participants, run by Hoffmann-La Roche at 3 sites in United States.
Trial summary
The purpose of this study is to assess the relative bioavailability of the high concentration liquid formulation (HCLF) of gantenerumab produced with the G4 process in comparison to the same HCLF of gantenerumab produced with the G3 process in healthy participants following single SC dose administration. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- Gantenerumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Aug 2017to 15 Dec 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy participant
- Body mass index (BMI) between 18.0 and 30.0 kilograms per meter-square (kg/m^2), inclusive
- Body weight between 55 to 110 kg inclusive
- Female participants with either non-childbearing potential or with childbearing potential who commit to remain abstinent or use acceptable contraceptive methods during the treatment period and until at least 6 months after the follow-up visit
- Women of childbearing potential must have a negative serum pregnancy test result at screening and Day 1
Who cannot join
- History of any clinically significant gastrointestinal, renal, hepatic, broncho-pulmonary, neurological, psychiatric, cardio-vascular, endocrinological, hematological or allergic disease, metabolic disorder, cancer, or cirrhosis
- History or suspicion of drugs of abuse addiction
- History or suspicion of alcohol addiction
- Pregnant or breastfeeding, or intending to become pregnant during the study or within 17 weeks after the last dose of study drug
- Prior administration of gantenerumab
- Clinically significant abnormalities (as judged by the investigator) in laboratory test results (including complete blood count, chemistry panel, and urinalysis)
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
PRA International Clinical Pharmacology Center (EDS US Clinic)
Lenexa, Kansas, 66219
PRA
Marlton, New Jersey, 08053
PRA Health Sciences
Salt Lake City, Utah, 84106
About this study
Official title: A Multi-Center, Randomized, Open-Label, Single-Dose, Parallel Group Study to Investigate the Relative Bioavailability of Gantenerumab Produced With the G4 Process in Comparison to Gantenerumab Produced With the G3 Process Following Administration by Subcutaneous Injection in Healthy Volunteers
The purpose of this study is to assess the relative bioavailability of the high concentration liquid formulation (HCLF) of gantenerumab produced with the G4 process in comparison to the same HCLF of gantenerumab produced with the G3 process in healthy participants following single SC dose administration.
Read the detailed description
This multi-center, randomized, open-label, single dose, parallel-group study will assess the relative bioavailability and the safety and tolerability of gantenerumab produced with the G4 process in comparison to gantenerumab produced with the G3 process. All participants will receive single SC dose of gantenerumab (manufactured by either the G3 or G4 process) on Day 1. The total duration of the study for each participant will be up to 21 weeks: Screening (up to 8 weeks); In-clinic period (Days -1 to 3); Out-patient period (Days 4 up to 68); and Safety Follow-up (up to 90 days after dosing).
- Conditions
- Healthy Participants
- Being tested
- Gantenerumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GantenerumabDrug
Also called RO4909832
Gantenerumab HCLF manufactured by either G3 or G4 process will be administered on Day 1 (in the abdomen).
| Study group | Role | What they receive |
|---|---|---|
| Gantenerumab G4 | Experimental | Participants will receive single dose of gantenerumab HCLF manufactured by G4 process on Day 1. Receives: Drug: Gantenerumab |
| Gantenerumab G3 | Experimental | Participants will receive single dose of gantenerumab HCLF manufactured by G3 process on Day 1. Receives: Drug: Gantenerumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed Plasma Concentration (Cmax) of Gantenerumab
Measured: Predose (any time before injection), 1, 6, and 12 hours postdose (after injection) on Day 1; on Days 2, 3, 4, 5, 6, 7, 8, 12, 21, 29, 43, 64, and 85
Area Under the Plasma Concentration-Time Curve From Time Zero (Predose) to Extrapolated Infinite Time (AUC 0-inf)
Measured: Predose (any time before injection), 1, 6, and 12 hours postdose (after injection) on Day 1; on Days 2, 3, 4, 5, 6, 7, 8, 12, 21, 29, 43, 64, and 85
Secondary outcomes (6)
Local Pain Assessments Using Visual Analog Scale (VAS)
Measured: After needle insertion, immediately postdose, 5 minutes (min), 10 min, 20 min, 1 hour, and 6 hours postdose on Day 1; on Days 2 and 3
Local Pain Assessments Using Verbal Rating Scale (VRS)
Measured: After needle insertion, immediately postdose, 5 min, 10 min, 20 min, 1 hour, and 6 hours postdose on Day 1; on Days 2 and 3
Skin Reactivity Assessment: Percentage of Participants by Severity of Injection Site Reactions
Measured: Immediately postdose, 10 min, 1 hour, and 6 hours postdose on Day 1; on Day 3
Skin Reactivity Assessment: Percentage of Participants by Size of Injection Site Reactions
Measured: Immediately postdose, 10 min, 1 hour, and 6 hours postdose on Day 1; on Day 3
Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs)
Measured: AEs: From Day 1 to Day 85; SAEs: From signing informed consent to end of study (maximum up to 5 months)
Percentage of Participants With Anti-Gantenerumab Antibodies
Measured: Predose (any time before injection) on Day 1 and on Day 85
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2017
- Study start1 Aug 2017
- Primary completion15 Dec 2017
- Study completion15 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 114 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
- NCT03236844
- Sponsor's protocol ID
- WP40052
- Status last verified
- Dec 2018
- First submitted
- 31 Jul 2017
- Last updated
- 12 Dec 2018
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Randomized, Open-Label, Single-Dose, Parallel Group Study to Investigate the Relative Bioavailability of Gantenerumab Produced With the G4 Process in Comparison to Gantenerumab Produced With the G3 Process Following Administration by Subcutaneous Injection in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT03236844
- Acronym / sponsor ID
- WP40052
- Conditions
- Healthy Participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 15 Dec 2017 (actual)
- Study completion
- 15 Dec 2017 (actual)
- First posted
- 2 Aug 2017 (actual)
- 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.
The purpose of this study is to assess the relative bioavailability of the high concentration liquid formulation (HCLF) of gantenerumab produced with the G4 process in comparison to the same HCLF of gantenerumab produced with the G3 process in healthy participants following single SC dose administration.
Detailed description
This multi-center, randomized, open-label, single dose, parallel-group study will assess the relative bioavailability and the safety and tolerability of gantenerumab produced with the G4 process in comparison to gantenerumab produced with the G3 process. All participants will receive single SC dose of gantenerumab (manufactured by either the G3 or G4 process) on Day 1. The total duration of the study for each participant will be up to 21 weeks: Screening (up to 8 weeks); In-clinic period (Days -1 to 3); Out-patient period (Days 4 up to 68); and Safety Follow-up (up to 90 days after dosing).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gantenerumab G4 | Experimental | Drug: GantenerumabParticipants will receive single dose of gantenerumab HCLF manufactured by G4 process on Day 1. |
| Gantenerumab G3 | Experimental | Drug: GantenerumabParticipants will receive single dose of gantenerumab HCLF manufactured by G3 process on Day 1. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Healthy participant
- Body mass index (BMI) between 18.0 and 30.0 kilograms per meter-square (kg/m^2), inclusive
- Body weight between 55 to 110 kg inclusive
- Female participants with either non-childbearing potential or with childbearing potential who commit to remain abstinent or use acceptable contraceptive methods during the treatment period and until at least 6 months after the follow-up visit
- Women of childbearing potential must have a negative serum pregnancy test result at screening and Day 1
Key exclusion criteria (7 listed)
- History of any clinically significant gastrointestinal, renal, hepatic, broncho-pulmonary, neurological, psychiatric, cardio-vascular, endocrinological, hematological or allergic disease, metabolic disorder, cancer, or cirrhosis
- History or suspicion of drugs of abuse addiction
- History or suspicion of alcohol addiction
- Pregnant or breastfeeding, or intending to become pregnant during the study or within 17 weeks after the last dose of study drug
- Prior administration of gantenerumab
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 |
|---|---|---|
| GantenerumabAlso: RO4909832Gantenerumab HCLF manufactured by either G3 or G4 process will be administered on Day 1 (in the abdomen). | Drug | Gantenerumab G3, Gantenerumab G4 |
Primary outcome
Maximum Observed Plasma Concentration (Cmax) of Gantenerumab
Time frame: Predose (any time before injection), 1, 6, and 12 hours postdose (after injection) on Day 1; on Days 2, 3, 4, 5, 6, 7, 8, 12, 21, 29, 43, 64, and 85
Area Under the Plasma Concentration-Time Curve From Time Zero (Predose) to Extrapolated Infinite Time (AUC 0-inf)
Time frame: Predose (any time before injection), 1, 6, and 12 hours postdose (after injection) on Day 1; on Days 2, 3, 4, 5, 6, 7, 8, 12, 21, 29, 43, 64, and 85
6 secondary outcomes
Local Pain Assessments Using Visual Analog Scale (VAS)
Time frame: After needle insertion, immediately postdose, 5 minutes (min), 10 min, 20 min, 1 hour, and 6 hours postdose on Day 1; on Days 2 and 3
Local Pain Assessments Using Verbal Rating Scale (VRS)
Time frame: After needle insertion, immediately postdose, 5 min, 10 min, 20 min, 1 hour, and 6 hours postdose on Day 1; on Days 2 and 3
Skin Reactivity Assessment: Percentage of Participants by Severity of Injection Site Reactions
Time frame: Immediately postdose, 10 min, 1 hour, and 6 hours postdose on Day 1; on Day 3
Skin Reactivity Assessment: Percentage of Participants by Size of Injection Site Reactions
Time frame: Immediately postdose, 10 min, 1 hour, and 6 hours postdose on Day 1; on Day 3
Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs)
Time frame: AEs: From Day 1 to Day 85; SAEs: From signing informed consent to end of study (maximum up to 5 months)
Percentage of Participants With Anti-Gantenerumab Antibodies
Time frame: Predose (any time before injection) on Day 1 and on Day 85
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 12 Dec 2018.
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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
3 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 Gantenerumab in people with Healthy Participants, run by Hoffmann-La Roche at 3 sites 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 5 inclusion and 7 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 12 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
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?
Maximum Observed Plasma Concentration (Cmax) of Gantenerumab (time frame: Predose (any time before injection), 1, 6, and 12 hours postdose (after injection) on Day 1; on Days 2, 3, 4, 5, 6, 7, 8, 12, 21, 29, 43, 64, and 85). The study lists 2 primary outcomes in all. 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 12 Dec 2018.