Healthy VolunteerPhase 1NCT02742779
A Study to Determine the Safety, Tolerability, and Pharmacokinetics of GDC-0310 in Healthy Volunteers
A Phase 1 study testing GDC-0310 in people with Healthy Volunteer, run by Genentech, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the safety and tolerability of single and multiple orally ascending doses of GDC-0310 administered in healthy participants as 4 parts including Part 1- a single dose (SD) part using a powder-in-capsule (PIC) formulation, Part 2- a multiple dose (MD) part using a PIC… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- GDC-0310
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 95 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2015to 7 Jun 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female participants of non-childbearing potential must meet the criteria defined in the protocol
- Body mass index within the range of 18.0 to 30.0 kilograms per meter square (kg/m^2), inclusive, and a minimum weight of 50.0 kg
Who cannot join
- Have a clinically significant medical condition (e.g., hypertension; diabetes; impaired cardiac, renal or hepatic function; hyperthyroidism or hypothyroidism; neurological disorder; pain condition; hematologic disorder; psychiatric disorders requiring chronic medication) including any medical condition requiring treatment with medication (other than study drugs and medications specifically allowed by this protocol) during participation in the study
- Evidence of any hepatic impairment including any abnormal levels (i.e., greater than [>] 1 × the upper limit of normal) of alkaline phosphatase, gamma glutamyl transpeptidase, alanine transaminase, aspartate aminotransferase or bilirubin
- Evidence of clinically significant renal impairment defined as >1.3 × upper limit of normal creatinine
- History or presence of alcoholism or alcohol or substance abuse (not including nicotine or caffeine) within the previous 2 years or routinely consume 2 or more alcohol-containing beverages per day or more than 10 units of alcohol per week (1 unit =150 milliliter (mL) of wine, 360 mL of beer, or 45 mL of 40 percent (%) alcohol)
- Have a positive urine drug test at screening or check-in or any other point during the study
- Are habituated to analgesic drugs (i.e., routine use of oral analgesics 5 or more times per week) or have a history of chronic pain requiring opiate use
Show all 12Show fewer
- Have used tobacco or nicotine-containing products within 3 months before study drug administration
- Have clinically significant abnormal laboratory values as determined by the principal investigator
- Have used any prescription or over-the-counter medication or supplement within 14 days or 5 times the elimination half-life (whichever is longer) before administration of study drug and until the end of their participation in the study
- History of seizures, including in first degree relatives
- History of heritable myopathy, weakness, or paralysis, including in first degree relatives indicative of familial periodic paralysis
- Current treatment with medications that are well known to prolong the QT interval
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Randomized, Single and Multiple Ascending Dose, Placebo-Controlled, Double-Blind Study to Determine the Safety, Tolerability, and Pharmacokinetics of GDC-0310 in Healthy Volunteers
The purpose of this study is to evaluate the safety and tolerability of single and multiple orally ascending doses of GDC-0310 administered in healthy participants as 4 parts including Part 1- a single dose (SD) part using a powder-in-capsule (PIC) formulation, Part 2- a multiple dose (MD) part using a PIC formulation, Part 3- a SD part using a solution formulation, and Part 4- a MD part using a solution formulation. Effects of food on pharmacokinetics (PK) will also be explored.
- Conditions
- Healthy Volunteer
- Being tested
- GDC-0310, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GDC-0310Drug
Participants will receive single or multiple ascending doses of GDC-0310 orally in fasted or fed state.
PlaceboDrug
Participants will receive placebo matched to GDC-0310 as single or multiple oral dose in fasted or fed state.
| Study group | Role | What they receive |
|---|---|---|
| High-Fat Meal SD Cohort: PIC (Part 1) | Experimental | Participants will receive GDC-0310 single ascending dose based on PK results from earlier SD cohorts up to an established dose yielding at least a 2-fold exposure margin to the MTD administered orally following a high-fat meal after a 8-hour/overnight fast using PIC on Day 1 of the treatment period (5 days) in an additional cohort of Part 1. Receives: Drug: GDC-0310 |
| High-Fat Meal SD Cohort: Solution Formulation (Part 3) | Experimental | Participants will receive GDC-0310 single ascending dose based on PK results from earlier SD cohorts up to an established dose yielding at least a 2-fold exposure margin to the MTD administered orally following a high-fat meal after a 8-hour/overnight fast using solution on Day 1 of the treatment period (5 days) in an additional cohort of Part 3. Receives: Drug: GDC-0310 |
| Low-Fat Meal SD Cohort: PIC (Part 1) | Experimental | Participants will receive GDC-0310 single ascending dose given orally using PIC based on PK results from earlier SD cohorts up to an established dose yielding at least a 2-fold exposure margin to the MTD administered orally following a low-fat meal after an 8-hour/overnight fast using PIC on Day 1 of the treatment period (5 days) in an additional cohort of Part 1. Receives: Drug: GDC-0310 |
| Low-Fat Meal SD Cohort: Solution Formulation (Part 3) | Experimental | Participants will receive GDC-0310 single ascending dose given orally using PIC based on PK results from earlier SD cohorts up to an established dose yielding at least a 2-fold exposure margin to the MTD administered orally following a low-fat meal after an 8-hour/overnight fast using solution on Day 1 of the treatment period (5 days) in an additional cohort of Part 1. Receives: Drug: GDC-0310 |
| MD Cohort: PIC (Part 2) | Experimental | Participants will receive multiple ascending dose administered orally using PIC from Day 1 to Day 13 twice daily (BID) or may even be thrice daily (TID) or four times a day (QD) depending on clinical PK, followed by morning dose on Day 14 in 7 cohorts of Part 2. Receives: Drug: GDC-0310 |
| MD Cohort: Solution Formulation (Part 4) | Experimental | Participants will receive multiple ascending dose in fed or fast condition, administered orally using solution from Day 1 to Day 13 BID or may even be TID or QD depending on clinical PK, followed by morning dose on Day 14 in 7 cohorts of Part 2. Receives: Drug: GDC-0310 |
| Placebo PIC | Placebo comparator | Participants will receive placebo matched to GDC-0310 single or multiple ascending dose administered orally in the fasted (SD cohorts) or fed state using PIC on Day 1 of the treatment period (5 days) to the SD cohorts and from Day 1 to 14 BID or may even be TID or QD depending on clinical PK, to the MD cohorts. Receives: Drug: Placebo |
| Placebo Solution | Placebo comparator | Participants will receive placebo matched to GDC-0310 single or multiple ascending dose administered orally in the fasted (SD cohorts) or fed state using PIC on Day 1 of the treatment period (5 days) to the SD cohorts and from Day 1 to 14 BID or may even be TID or QD depending on clinical PK, to the MD cohorts. Receives: Drug: Placebo |
| SD Cohort: PIC (Part 1) | Experimental | Participants will receive GDC-0310 single ascending dose administered orally in the fasted state using PIC on Day 1 of the treatment period (5 days) in the 9 cohorts of Part 1. Receives: Drug: GDC-0310 |
| SD Cohort: Solution Formulation (Part 3) | Experimental | Participants will receive GDC-0310 single ascending dose administered orally in the fasted state using solution formulation on Day 1 of the treatment period (5 days) in the 9 cohorts of Part 3. Receives: Drug: GDC-0310 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Serious Adverse Events (SAEs) and Adverse Events (AEs)
Measured: Baseline up to Month 9
Secondary outcomes (11)
Maximum Plasma Concentration (Cmax) of GDC-0310
SD Cohort: Pre-dose (PD) (Hour[H] 0),5 minutes,0.25,0.5,1,1.5,2,3,4,6,8,10,12,13,14,16,24,48,96H post-dose(PoD); MD Cohort:PD H0,5 minutes,0.25,0.5,1,1.5,2,3,4,6,8,10,12,13,14,16H PoD on Day 1,14;Pre a.m. dose (H0) on Day 2,3,4,5,7,9,11,13;24H PoD on Day 15
Measured: Pre dose up to Day 15 (detailed timeframe has been reported in the description)
Minimum Plasma Concentration (Cmin) of GDC-0310
SD Cohort: PD H 0,5 minutes,0.25,0.5,1,1.5,2,3,4,6,8,10,12,13,14,16,24,48,96H PoD; MD Cohort: PD H0,5 minutes,0.25,0.5,1,1.5,2,3,4,6,8,10,12,13,14,16H PoD on Day 1,14; Pre a.m. dose (H0) on Day 2,3,4,5,7,9,11,13;24H PoD on Day 15
Measured: Pre dose up to Day 15 (detailed timeframe has been reported in the description)
Time to Maximum Plasma Concentration (tmax) of GDC-0310
SD Cohort: PD H 0,5 minutes,0.25,0.5,1,1.5,2,3,4,6,8,10,12,13,14,16,24,48,96H PoD; MD Cohort: PD H0,5 minutes,0.25,0.5,1,1.5,2,3,4,6,8,10,12,13,14,16H PoD on Day 1,14; Pre a.m. dose (H0) on Day 2,3,4,5,7,9,11,13;24H PoD on Day 15
Measured: Pre dose up to Day 15 (detailed timeframe has been reported in the description)
Area Under the Concentration-Time Curve (AUC) of GDC-0310
SD Cohort: PD H 0,5 minutes,0.25,0.5,1,1.5,2,3,4,6,8,10,12,13,14,16,24,48,96H PoD; MD Cohort: PD H0,5 minutes,0.25,0.5,1,1.5,2,3,4,6,8,10,12,13,14,16H PoD on Day 1,14; Pre a.m. dose (H0) on Day 2,3,4,5,7,9,11,13;24H PoD on Day 15
Measured: Pre dose up to Day 15 (detailed timeframe has been reported in the description)
Apparent Clearance (CL/F) of GDC-0310
SD Cohort: PD H 0,5 minutes,0.25,0.5,1,1.5,2,3,4,6,8,10,12,13,14,16,24,48,96H PoD; MD Cohort: PD H0,5 minutes,0.25,0.5,1,1.5,2,3,4,6,8,10,12,13,14,16H PoD on Day 1,14; Pre a.m. dose (H0) on Day 2,3,4,5,7,9,11,13;24H PoD on Day 15
Measured: Pre dose up to Day 15 (detailed timeframe has been reported in the description)
Apparent Terminal Volume of Distribution (Vz/F) of GDC-0310
SD Cohort: PD H 0,5 minutes,0.25,0.5,1,1.5,2,3,4,6,8,10,12,13,14,16,24,48,96H PoD; MD Cohort: PD H0,5 minutes,0.25,0.5,1,1.5,2,3,4,6,8,10,12,13,14,16H PoD on Day 1,14; Pre a.m. dose (H0) on Day 2,3,4,5,7,9,11,13;24H PoD on Day 15
Measured: Pre dose up to Day 15 (detailed timeframe has been reported in the description)
Apparent Terminal Elimination Rate Constant (ke) of GDC-0310
SD Cohort: PD H 0,5 minutes,0.25,0.5,1,1.5,2,3,4,6,8,10,12,13,14,16,24,48,96H PoD; MD Cohort: PD H0,5 minutes,0.25,0.5,1,1.5,2,3,4,6,8,10,12,13,14,16H PoD on Day 1,14; Pre a.m. dose (H0) on Day 2,3,4,5,7,9,11,13;24H PoD on Day 15
Measured: Pre dose up to Day 15 (detailed timeframe has been reported in the description)
Apparent Terminal Half-Life (t1/2) of GDC-0310
SD Cohort: PD H 0,5 minutes,0.25,0.5,1,1.5,2,3,4,6,8,10,12,13,14,16,24,48,96H PoD; MD Cohort: PD H0,5 minutes,0.25,0.5,1,1.5,2,3,4,6,8,10,12,13,14,16H PoD on Day 1,14; Pre a.m. dose (H0) on Day 2,3,4,5,7,9,11,13;24H PoD on Day 15
Measured: Pre dose up to Day 15 (detailed timeframe has been reported in the description)
Pharmacokinetics (PK) Dose Proportionality as Assessed With Cmax of GDC-0310
SD Cohort: PD H 0,5 minutes,0.25,0.5,1,1.5,2,3,4,6,8,10,12,13,14,16,24,48,96H PoD; MD Cohort: PD H0,5 minutes,0.25,0.5,1,1.5,2,3,4,6,8,10,12,13,14,16H PoD on Day 1,14; Pre a.m. dose (H0) on Day 2,3,4,5,7,9,11,13;24H PoD on Day 15
Measured: Pre dose up to Day 15 (detailed timeframe has been reported in the description)
PK Dose Proportionality as Assessed With AUC of GDC-0310
SD Cohort: PD H 0,5 minutes,0.25,0.5,1,1.5,2,3,4,6,8,10,12,13,14,16,24,48,96H PoD; MD Cohort: PD H0,5 minutes,0.25,0.5,1,1.5,2,3,4,6,8,10,12,13,14,16H PoD on Day 1,14; Pre a.m. dose (H0) on Day 2,3,4,5,7,9,11,13;24H PoD on Day 15
Measured: Pre dose up to Day 15 (detailed timeframe has been reported in the description)
Accumulation Ratio for MD Cohort
PD H0,5 minutes,0.25,0.5,1,1.5,2,3,4,6,8,10,12,13,14,16H PoD on Day 1,14; Pre a.m. dose (H0) on Day 2,3,4,5,7,9,11,13;24H PoD on Day 15
Measured: Pre dose up to Day 15 (detailed timeframe has been reported in the description)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2016 (estimated)
- Study start15 Sep 2015
- Primary completion7 Jun 2017
- Study completion7 Jun 2017
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 Genentech, Inc.The 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02742779
- Sponsor's protocol ID
- GN29829
- Status last verified
- Feb 2020
- First submitted
- 11 Mar 2016
- Last updated
- 20 Feb 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomized, Single and Multiple Ascending Dose, Placebo-Controlled, Double-Blind Study to Determine the Safety, Tolerability, and Pharmacokinetics of GDC-0310 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02742779
- Acronym / sponsor ID
- GN29829
- Conditions
- Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Sep 2015 (actual)
- Primary completion
- 7 Jun 2017 (actual)
- Study completion
- 7 Jun 2017 (actual)
- First posted
- 19 Apr 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.
The purpose of this study is to evaluate the safety and tolerability of single and multiple orally ascending doses of GDC-0310 administered in healthy participants as 4 parts including Part 1- a single dose (SD) part using a powder-in-capsule (PIC) formulation, Part 2- a multiple dose (MD) part using a PIC formulation, Part 3- a SD part using a solution formulation, and Part 4- a MD part using a solution formulation. Effects of food on pharmacokinetics (PK) will also be explored.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| High-Fat Meal SD Cohort: PIC (Part 1) | Experimental | Drug: GDC-0310Participants will receive GDC-0310 single ascending dose based on PK results from earlier SD cohorts up to an established dose yielding at least a 2-fold exposure margin to the MTD administered orally following a high-fat meal after a 8-hour/overnight fast using PIC on Day 1 of the treatment period (5 days) in an additional cohort of Part 1. |
| High-Fat Meal SD Cohort: Solution Formulation (Part 3) | Experimental | Drug: GDC-0310Participants will receive GDC-0310 single ascending dose based on PK results from earlier SD cohorts up to an established dose yielding at least a 2-fold exposure margin to the MTD administered orally following a high-fat meal after a 8-hour/overnight fast using solution on Day 1 of the treatment period (5 days) in an additional cohort of Part 3. |
| Low-Fat Meal SD Cohort: PIC (Part 1) | Experimental | Drug: GDC-0310Participants will receive GDC-0310 single ascending dose given orally using PIC based on PK results from earlier SD cohorts up to an established dose yielding at least a 2-fold exposure margin to the MTD administered orally following a low-fat meal after an 8-hour/overnight fast using PIC on Day 1 of the treatment period (5 days) in an additional cohort of Part 1. |
| Low-Fat Meal SD Cohort: Solution Formulation (Part 3) | Experimental | Drug: GDC-0310Participants will receive GDC-0310 single ascending dose given orally using PIC based on PK results from earlier SD cohorts up to an established dose yielding at least a 2-fold exposure margin to the MTD administered orally following a low-fat meal after an 8-hour/overnight fast using solution on Day 1 of the treatment period (5 days) in an additional cohort of Part 1. |
| MD Cohort: PIC (Part 2) | Experimental | Drug: GDC-0310Participants will receive multiple ascending dose administered orally using PIC from Day 1 to Day 13 twice daily (BID) or may even be thrice daily (TID) or four times a day (QD) depending on clinical PK, followed by morning dose on Day 14 in 7 cohorts of Part 2. |
| MD Cohort: Solution Formulation (Part 4) | Experimental | Drug: GDC-0310Participants will receive multiple ascending dose in fed or fast condition, administered orally using solution from Day 1 to Day 13 BID or may even be TID or QD depending on clinical PK, followed by morning dose on Day 14 in 7 cohorts of Part 2. |
| Placebo PIC | Placebo comparator | Drug: PlaceboParticipants will receive placebo matched to GDC-0310 single or multiple ascending dose administered orally in the fasted (SD cohorts) or fed state using PIC on Day 1 of the treatment period (5 days) to the SD cohorts and from Day 1 to 14 BID or may even be TID or QD depending on clinical PK, to the MD cohorts. |
| Placebo Solution | Placebo comparator | Drug: PlaceboParticipants will receive placebo matched to GDC-0310 single or multiple ascending dose administered orally in the fasted (SD cohorts) or fed state using PIC on Day 1 of the treatment period (5 days) to the SD cohorts and from Day 1 to 14 BID or may even be TID or QD depending on clinical PK, to the MD cohorts. |
| SD Cohort: PIC (Part 1) | Experimental | Drug: GDC-0310Participants will receive GDC-0310 single ascending dose administered orally in the fasted state using PIC on Day 1 of the treatment period (5 days) in the 9 cohorts of Part 1. |
| SD Cohort: Solution Formulation (Part 3) | Experimental | Drug: GDC-0310Participants will receive GDC-0310 single ascending dose administered orally in the fasted state using solution formulation on Day 1 of the treatment period (5 days) in the 9 cohorts of Part 3. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Female participants of non-childbearing potential must meet the criteria defined in the protocol
- Body mass index within the range of 18.0 to 30.0 kilograms per meter square (kg/m^2), inclusive, and a minimum weight of 50.0 kg
Key exclusion criteria (12 listed)
- Have a clinically significant medical condition (e.g., hypertension; diabetes; impaired cardiac, renal or hepatic function; hyperthyroidism or hypothyroidism; neurological disorder; pain condition; hematologic disorder; psychiatric disorders requiring chronic medication) including any medical condition requiring treatment with medication (other than study drugs and medications specifically allowed by this protocol) during participation in the study
- Evidence of any hepatic impairment including any abnormal levels (i.e., greater than [>] 1 × the upper limit of normal) of alkaline phosphatase, gamma glutamyl transpeptidase, alanine transaminase, aspartate aminotransferase or bilirubin
- Evidence of clinically significant renal impairment defined as >1.3 × upper limit of normal creatinine
- History or presence of alcoholism or alcohol or substance abuse (not including nicotine or caffeine) within the previous 2 years or routinely consume 2 or more alcohol-containing beverages per day or more than 10 units of alcohol per week (1 unit =150 milliliter (mL) of wine, 360 mL of beer, or 45 mL of 40 percent (%) alcohol)
- Have a positive urine drug test at screening or check-in or any other point during the study
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 |
|---|---|---|
| GDC-0310Participants will receive single or multiple ascending doses of GDC-0310 orally in fasted or fed state. | Drug | High-Fat Meal SD Cohort: PIC (Part 1), High-Fat Meal SD Cohort: Solution Formulation (Part 3), Low-Fat Meal SD Cohort: PIC (Part 1), Low-Fat Meal SD Cohort: Solution Formulation (Part 3), MD Cohort: PIC (Part 2), MD Cohort: Solution Formulation (Part 4), SD Cohort: PIC (Part 1), SD Cohort: Solution Formulation (Part 3) |
| PlaceboParticipants will receive placebo matched to GDC-0310 as single or multiple oral dose in fasted or fed state. | Drug | Placebo PIC, Placebo Solution |
Primary outcome
Percentage of Participants With Serious Adverse Events (SAEs) and Adverse Events (AEs)
Time frame: Baseline up to Month 9
11 secondary outcomes
Maximum Plasma Concentration (Cmax) of GDC-0310
Time frame: Pre dose up to Day 15 (detailed timeframe has been reported in the description)
Minimum Plasma Concentration (Cmin) of GDC-0310
Time frame: Pre dose up to Day 15 (detailed timeframe has been reported in the description)
Time to Maximum Plasma Concentration (tmax) of GDC-0310
Time frame: Pre dose up to Day 15 (detailed timeframe has been reported in the description)
Area Under the Concentration-Time Curve (AUC) of GDC-0310
Time frame: Pre dose up to Day 15 (detailed timeframe has been reported in the description)
Apparent Clearance (CL/F) of GDC-0310
Time frame: Pre dose up to Day 15 (detailed timeframe has been reported in the description)
Apparent Terminal Volume of Distribution (Vz/F) of GDC-0310
Time frame: Pre dose up to Day 15 (detailed timeframe has been reported in the description)
Apparent Terminal Elimination Rate Constant (ke) of GDC-0310
Time frame: Pre dose up to Day 15 (detailed timeframe has been reported in the description)
Apparent Terminal Half-Life (t1/2) of GDC-0310
Time frame: Pre dose up to Day 15 (detailed timeframe has been reported in the description)
Pharmacokinetics (PK) Dose Proportionality as Assessed With Cmax of GDC-0310
Time frame: Pre dose up to Day 15 (detailed timeframe has been reported in the description)
PK Dose Proportionality as Assessed With AUC of GDC-0310
Time frame: Pre dose up to Day 15 (detailed timeframe has been reported in the description)
Accumulation Ratio for MD Cohort
Time frame: Pre dose up to Day 15 (detailed timeframe has been reported in the description)
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 20 Feb 2020.
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Screening Protocol
Pain
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 GDC-0310 in people with Healthy Volunteer, run by Genentech, Inc. 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 2 inclusion and 12 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 20 Feb 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. 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 Serious Adverse Events (SAEs) and Adverse Events (AEs) (time frame: Baseline up to Month 9). 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 20 Feb 2020.