A study to evaluate safety and pharmacokinetics (processing by the body) of single ascending doses of GDC-5780 in healthy participants
| ISRCTN | ISRCTN16073754 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16073754 |
| Secondary identifying numbers | GV43221 |
- Submission date
- 02/02/2022
- Registration date
- 09/02/2022
- Last edited
- 07/02/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
This study will evaluate the safety (side effects) and how the body processes the treatment (pharmacokinetics) of the drug GDC-5780 in healthy volunteers.
The purpose of this first-in-human study is:
1. To find out how safe GDC-5780 is when given as a single dose
2. To find out how GDC-5780 will be distributed and eliminated from the body
GDC-5780 is an experimental drug, which means health authorities have not approved GDC-5780 for the treatment of any disease, and it has not been tested in people before this study.
Who can participate?
Healthy participants aged between 18 to 65 years.
What does the study involve?
Participants may be asked to be in the study for up to 40 days. This includes:
- A Screening Period of up to 28 days before the start of the study where tests will be done to check if the participants are eligible to take part in the study.
- Treatment Period where participants will have to check in to the clinic 2 days before receiving the study treatment and will have to stay in the clinic for 5 nights and receive a single dose of GDC-5780 or placebo (drug without an active substance).
- Follow-up Period where participants will have to report to the clinic for a check-up 2 times, with the last visit taking place about 14 days after the dose of study drug.
The first 8 participants will get a single dose of GDC-5780 or placebo as intravenous (IV) infusion (through the vein) over 2 hours. The dose for new participants joining the study will be adjusted according to the test results of previous participants. Participants joining the study at later stages will get higher doses of the study drug.
All participants will be closely monitored throughout the study to ensure that the study drug is safe and tolerable. After the dose of study treatment, the study doctor will follow-up participants for 14 days.
What are the possible benefits and risks of participating?
Participants will not receive any benefit from participating in this study, but the information that is learned may help people with UTIs in the future.
No clinical information is available for GDC-5780 to date, as this is a first-in-human study. The expected risks for GDC-5780, determined according to the mechanism of action and results from nonclinical studies (laboratory studies on animals) are listed below:
- Reaction during or following the drug infusion that may mimic an allergic reaction and could include symptoms such as fever, chills, rash, low blood pressure, and difficulty breathing
- Sudden decrease in kidney function
- Transient loss of muscle coordination; awkward, uncoordinated walking; or unsteadiness when walking
There may be a risk in exposing an unborn child to the study drug, and all risks are not known at this time. Participants must take precautions to avoid exposing an unborn child to the study drug. Participants who are pregnant, become pregnant, or are currently breastfeeding, cannot take part in this study.
Where is the study run from?
Roche (USA)
When is the study starting and how long is it expected to run for?
October 2021 to August 2022
Who is funding the study?
Roche (USA)
Who is the main contact?
global-roche-genentech-trials@gene.com
Contact information
Public
1 DNA Way
South San Francisco
94080
United States of America
| Phone | +1 888-662-6728 |
|---|---|
| global-roche-genentech-trials@gene.com |
Study information
| Study design | Phase I first-in-human participant- and investigator-blinded randomized placebo-controlled dose-escalation study in healthy participants |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | No participant information sheet available |
| Scientific title | A Phase I, randomized, double-blind, single ascending dose study to evaluate the safety and pharmacokinetics of GDC-5780 in healthy subjects |
| Study objectives | The purpose of this study is to evaluate the safety and pharmacokinetics of single doses of GDC-5780 in healthy participants. |
| Ethics approval(s) | Approved 09/12/2021, WCG IRB (1019 39th Ave SE, Suite 120, Puyallup WA98374, USA; +1 800-562-4789; no email provided) ref: 20216447 |
| Health condition(s) or problem(s) studied | Safety and pharmacokinetics of single doses of GDC-5780 in healthy participants |
| Intervention | 1. GDC-5780 – Single Ascending Dose: Participants will receive a single dose of GDC-5780 as intravenous (IV) infusion over 2 hours on Day 1 in the first cohort. The dose will be escalated in subsequent cohorts, as per the Safety Monitoring Committee decision in consultation with the investigator. 2. Placebo - Participants will receive a single dose of placebo as an IV infusion over 2 hours on Day 1. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase I |
| Drug / device / biological / vaccine name(s) | GDC-5780 |
| Primary outcome measure | 1. Percentage of participants with adverse events (AEs) measured from Day 1 until 14 days after the dose of study drug 2. Percentage of participants with adverse events based on severity per Division of AIDS (DAIDS) Toxicity Grading Scale from Day 1 until 14 days after the dose of study drug 3. Percentage of participants with clinically significant change in vital signs measured using body temperature, respiratory rate, pulse rate, and blood pressure from Day 1 until 14 days after the dose of study drug 4. Percentage of participants with clinically significant laboratory test abnormalities measured using blood and urine samples from Day 1 until 14 days after the dose of study drug 5. Percentage of participants with clinically significant electrocardiogram (ECG) abnormalities measured using single 12-lead ECG or Holter ECG recordings from Day 1 until 14 days after the dose of study drug |
| Secondary outcome measures | 1. Maximum observed plasma concentration (Cmax) of GDC-5780 measured from blood samples taken at multiple timepoints over Days 1, 2, 3, and 4 2. Time to reach maximum plasma concentration (Tmax) of GDC-5780, measured from blood samples taken at multiple timepoints over Days 1, 2, 3, and 4 3. Terminal half-life (t1/2) of GDC-5780 measured from blood samples taken at multiple timepoints over Days 1, 2, 3, and 4 4. Area under the plasma concentration-time curve from time zero to 24 hours after dosing (AUC (0-24)) with GDC-5780 measured from blood samples taken at multiple timepoints over Days 1, 2, 3, and 4 5. Area under the plasma concentration-time curve from time zero to the time of last quantifiable concentration (AUC (0-last)) of GDC-5780 measured from blood samples taken at multiple timepoints over Days 1, 2, 3, and 4 6. Area under the plasma concentration-time curve from time zero to infinity (AUC (0-infinity)) of GDC-5780 measured from blood samples taken at multiple timepoints over Days 1, 2, 3, and 4 7. Renal clearance (CLr) measured from multiple pooled urine samples taken at multiple timepoints from Day 1 to Day 4 8. Fractional excretion of GDC-5780 measured from multiple pooled urine samples taken at multiple timepoints from Day 1 to Day 4 |
| Overall study start date | 26/10/2021 |
| Completion date | 05/08/2022 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 56 |
| Key inclusion criteria | 1. Body mass index ≥18.5 and <30 kg/m² 2. Body temperature of 35°C−37.6°C at screening 3. Systolic blood pressure of 90−139 mmHg and diastolic blood pressure of 45−89 mmHg at screening 4. Agree to abstain from consumption of grapefruit, grapefruit hybrids, oranges, orange hybrids, pomelos, exotic citrus fruits, and all orange and grapefruit-type fruit juices from 48 hours prior to check-in until clinic check-out (i.e., end of residential stay) 5. Agree to abstain from consumption of alcohol from 48 hours prior to clinic check-in until clinic check-out 6. Agreement to abstain from consumption of caffeine-containing foods and beverages (e.g., coffee, tea, chocolate, energy drinks, soda) from 48 hours prior to clinic check-in until clinic check-out |
| Key exclusion criteria | 1. Pregnancy or breastfeeding, or intention of becoming pregnant during the study or within 14 days after the dose of study drug 2. Planned procedure or surgery during the study 3. Clinical laboratory values outside the normal reference range for the test laboratory at screening, Day −2, or Day −1. Participants with an estimated glomerular filtration rate <90 mL/min/1.73 m² at screening, Day −2, or Day −1, as calculated using the Chronic Kidney Disease Epidemiology Collaboration equation, must be excluded from the study 4. Positive HIV test at screening 5. Positive hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), hepatitis B virus (HBV) DNA test at screening, hepatitis C virus (HCV) 6. Urine sample positive for drugs of abuse at screening or Day −2 7. Treatment with investigational biologic therapy within 90 days or 5 drug elimination half-lives (if known), whichever is longer, prior to initiation of study drug 8. Acute illness within 14 days prior to screening 9. Vaccination within 14 days prior to initiation of study drug |
| Date of first enrolment | 02/03/2022 |
| Date of final enrolment | 22/07/2022 |
Locations
Countries of recruitment
- United States of America
Study participating centre
Lenexa, KS
66219
United States of America
Sponsor information
Industry
1 DNA Way
South San Francisco
94080
United States of America
| Phone | +1 888-662-6728 |
|---|---|
| global-roche-genentech-trials@gene.com | |
| Website | http://www.roche.com/about_roche/roche_worldwide.htm |
"ROR" |
https://ror.org/011qkaj49 |
Funders
Funder type
Industry
Private sector organisation / For-profit companies (industry)
- Alternative name(s)
- Hoffman-La Roche, F. Hoffmann-La Roche Ltd.
- Location
- Switzerland
Results and Publications
| Intention to publish date | 05/08/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available due to participant-level data not being a regulatory requirement |
Editorial Notes
Trial's existence confirmed by WCG IRB.
