Ulcerative ColitisPhase 1NCT02209987
Absolute Bioavailability, Safety, and Tolerability of Subcutaneous GS-5745 in Healthy Adults
A Phase 1 study testing GS-5745 SC and GS-5745 IV in people with Ulcerative Colitis, run by Gilead Sciences at 1 site in New Zealand.
Trial summary
This study will estimate the absolute bioavailability of subcutaneously injected GS-5745, characterize the safety, tolerability, and pharmacokinetics (PK) of GS-5745 after subcutaneous (SC) injection and intravenous (IV) administration, and evaluate the formation of anti-GS-5745 antibodies after SC and IV… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- GS-5745 SC and GS-5745 IV
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteNew Zealand
- Study dates
- Aug 2014to Oct 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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- In the opinion of the investigator, individuals must be in good general health based upon medical history and physical examination
- Females, of childbearing potential, and males must agree to utilize protocol specific contraception methods
- Screening laboratory evaluations must be within defined thresholds
Who cannot join
- Infection with hepatitis B virus (HBV), hepatitis C virus (HCV) or human immunodeficiency virus (HIV)
- Pregnant and lactating females
- History of clinically significant illness (including psychiatric or cardiac) or any other medical disorder that may interfere with individual treatment and/or adherence to the protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Study to Evaluate the Absolute Bioavailability, Safety, and Tolerability of Subcutaneous GS-5745 in Healthy Subjects
This study will estimate the absolute bioavailability of subcutaneously injected GS-5745, characterize the safety, tolerability, and pharmacokinetics (PK) of GS-5745 after subcutaneous (SC) injection and intravenous (IV) administration, and evaluate the formation of anti-GS-5745 antibodies after SC and IV administration.
- Conditions
- Ulcerative Colitis
- Being tested
- GS-5745 SC, GS-5745 IV
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GS-5745 SCDrug
GS-5745 150 mg administered by SC injection formulated as a sterile, aqueous buffered solution in a single-use pre-filled syringe
GS-5745 IVDrug
GS-5745 150 mg administered by IV infusion formulated as a sterile, aqueous buffered solution in single-use glass vials
| Study group | Role | What they receive |
|---|---|---|
| GS-5745 SC | Experimental | Participants will receive a single dose of GS-5745 by SC injection. Receives: Drug: GS-5745 SC |
| GS-5745 IV | Experimental | Participants will receive a single dose of GS-5745 by IV infusion. Receives: Drug: GS-5745 IV |
What is being measured
The primary outcome is the main question the study is designed to answer.
PK profile of GS-5745
This composite endpoint will measure the plasma PK profile of GS-5745. The following parameters will be measured, where applicable:
- Cmax: maximum observed concentration of drug in plasma
- AUClast: concentration of drug from time zero to the last quantifiable concentration
- AUC0-inf: area under the plasma concentration versus time curve starting with time zero to infinity
Measured: Predose and postdose on Days 1 and Day 11, and Weeks 2, 3, 4, 6, and 8
Secondary outcomes (1)
Incidences of adverse events and laboratory abnormalities
This composite endpoint will measure the safety and tolerability profile of GS-5745.
Measured: Up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2014 (estimated)
- Study startAug 2014
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- More trials run by Gilead SciencesThe 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
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bittoo Kanwar, MD, Study director, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02209987
- Sponsor's protocol ID
- GS-US-326-1430
- Status last verified
- Oct 2014
- First submitted
- 4 Aug 2014
- Last updated
- 27 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study to Evaluate the Absolute Bioavailability, Safety, and Tolerability of Subcutaneous GS-5745 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02209987
- Acronym / sponsor ID
- GS-US-326-1430
- Conditions
- Ulcerative Colitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- Aug 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 6 Aug 2014 (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 study will estimate the absolute bioavailability of subcutaneously injected GS-5745, characterize the safety, tolerability, and pharmacokinetics (PK) of GS-5745 after subcutaneous (SC) injection and intravenous (IV) administration, and evaluate the formation of anti-GS-5745 antibodies after SC and IV administration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GS-5745 SC | Experimental | Drug: GS-5745 SCParticipants will receive a single dose of GS-5745 by SC injection. |
| GS-5745 IV | Experimental | Drug: GS-5745 IVParticipants will receive a single dose of GS-5745 by IV infusion. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- In the opinion of the investigator, individuals must be in good general health based upon medical history and physical examination
- Females, of childbearing potential, and males must agree to utilize protocol specific contraception methods
- Screening laboratory evaluations must be within defined thresholds
Key exclusion criteria (3 listed)
- Infection with hepatitis B virus (HBV), hepatitis C virus (HCV) or human immunodeficiency virus (HIV)
- Pregnant and lactating females
- History of clinically significant illness (including psychiatric or cardiac) or any other medical disorder that may interfere with individual treatment and/or adherence to the protocol
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 |
|---|---|---|
| GS-5745 SCGS-5745 150 mg administered by SC injection formulated as a sterile, aqueous buffered solution in a single-use pre-filled syringe | Drug | GS-5745 SC |
| GS-5745 IVGS-5745 150 mg administered by IV infusion formulated as a sterile, aqueous buffered solution in single-use glass vials | Drug | GS-5745 IV |
Primary outcome
PK profile of GS-5745
Time frame: Predose and postdose on Days 1 and Day 11, and Weeks 2, 3, 4, 6, and 8
This composite endpoint will measure the plasma PK profile of GS-5745. The following parameters will be measured, where applicable: * Cmax: maximum observed concentration of drug in plasma * AUClast: concentration of drug from time zero to the last quantifiable concentration * AUC0-inf: area under the plasma concentration versus time curve starting with time zero to infinity
1 secondary outcome
Incidences of adverse events and laboratory abnormalities
Time frame: Up to 8 weeks
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 27 Oct 2014.
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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.
Bittoo Kanwar, MD study director
Gilead Sciences
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 GS-5745 SC and GS-5745 IV in people with Ulcerative Colitis, run by Gilead Sciences at 1 site in New Zealand.
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 3 inclusion and 3 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 27 Oct 2014. 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 New Zealand. 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?
PK profile of GS-5745 (time frame: Predose and postdose on Days 1 and Day 11, and Weeks 2, 3, 4, 6, and 8). 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 27 Oct 2014.