Ischemic Heart DiseasePhase 1NCT01847391
A Phase 1 Study to Assess the Safety,Tolerability, and Pharmacokinetics of GS-6615 in Healthy Subjects
A Phase 1 study testing GS-6615 in people with Ischemic Heart Disease, run by Gilead Sciences at 1 site in United States.
Trial summary
This is a phase 1, single-blind, randomized, placebo-controlled, multiple ascending dose study aimed to assess the safety, tolerability, and pharmacokinetics of GS-6615 in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Ischemic Heart Disease
- What is being tested?
- GS-6615
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- May 2013to Nov 2013
- 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
- Weight of at least 50 kg with body mass index (BMI) between 18 and 30 kg/m2
- Female subjects must be of non-childbearing potential as defined per the protocol
- Male subjects with female partners of childbearing potential must be using protocol acceptable methods of contraception
- Willing and able to comply with the requirements of the protocol and directions
- Willing to avoid consumption of grapefruit, grapefruit juice and Seville oranges
- Willing to avoid consumption of nicotine (including nicotine gum) and alcoholic beverages
Who cannot join
- Ongoing or history of any medical or surgical condition that, in the judgment of the Investigator, might jeopardize the subject's safety or interfere with the study objectives
- History of meningitis or encephalitis, seizures, migraines, tremors, myoclonic jerks, sleep disorder, anxiety, syncope, head injuries or a family history of seizures
- Any abnormal ECG findings, abnormal laboratory value, or physical examination findings at Screening judged to be clinically significant
- Any abnormal neurological examination findings at Screening that is judged as clinically significant
- Hemoglobin < 12 g/dL
- Serology test positive for HIV, or hepatitis B or C
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- Positive urine drug test (including cotinine or ethanol)
- Use of systemic prescription medications or over the counter (OTC) medication, including multivitamins, and dietary and herbal supplement
- Use of any experimental or investigational drug or device within 30 days
- Female subjects who are of childbearing potential, pregnant or lactating
- Donation or loss of blood within 8 weeks and/or donation of plasma within 7 days
- History of drug or alcohol abuse
- Psychosocial or addictive disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Single-Blind, Randomized, Placebo-Controlled, Multiple Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of GS-6615 in Healthy Subjects
This is a phase 1, single-blind, randomized, placebo-controlled, multiple ascending dose study aimed to assess the safety, tolerability, and pharmacokinetics of GS-6615 in healthy subjects.
- Conditions
- Ischemic Heart Disease
- Being tested
- GS-6615, Placebo
- Keywords
- Ischemic Heart Disease, Heart Disease
- Medical subject headings
- Myocardial Ischemia, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GS-6615Drug
GS-6615 tablet(s) administered orally once daily
PlaceboDrug
Placebo tablet(s) to match GS-6615 administered orally once daily
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Randomized to 6 mg once daily (Days 1-7) followed by 3 mg once daily (Days 8-21) of GS-6615 or matching placebo Receives: Drug: GS-6615; Drug: Placebo |
| Cohort 2 | Experimental | Randomized to 12 mg once daily (Days 1-7) followed by 6 mg once daily (Days 8-21) of GS-6615 or matching placebo Receives: Drug: GS-6615; Drug: Placebo |
| Cohort 3 | Experimental | Randomized to 20 mg once daily (Days 1-7) followed by 9 mg once daily (Days 8-21) of GS-6615 or matching placebo Receives: Drug: GS-6615; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of GS-6615
The primary outcome measure is the safety and tolerability of GS-6615 including neurological findings, adverse events, clinical laboratory tests, vital signs and ECG data (PR, RR, QRS, QT, and QTc [Fridericia] interval).
Measured: Up to 65 days
Pharmacokinetic (PK) profile of GS-6615
The primary outcome measure is the PK profile of GS-6615 which will be measured with Cmax, Tmax, AUCtau, AUC0-∞, T1/2, CL/F, VSS/F, and R.
Measured: Up to 65 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2013 (estimated)
- Study startMay 2013
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Heart DiseaseStudies 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
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Elizabeth Layug, MD, Study director, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01847391
- Sponsor's protocol ID
- GS-US-279-0102
- Status last verified
- Nov 2013
- First submitted
- 2 May 2013
- Last updated
- 13 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Single-Blind, Randomized, Placebo-Controlled, Multiple Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of GS-6615 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01847391
- Acronym / sponsor ID
- GS-US-279-0102
- Conditions
- Ischemic Heart Disease
- Keywords
- Ischemic Heart Disease, Heart Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- May 2013
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 6 May 2013 (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 is a phase 1, single-blind, randomized, placebo-controlled, multiple ascending dose study aimed to assess the safety, tolerability, and pharmacokinetics of GS-6615 in healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: GS-6615, Drug: PlaceboRandomized to 6 mg once daily (Days 1-7) followed by 3 mg once daily (Days 8-21) of GS-6615 or matching placebo |
| Cohort 2 | Experimental | Drug: GS-6615, Drug: PlaceboRandomized to 12 mg once daily (Days 1-7) followed by 6 mg once daily (Days 8-21) of GS-6615 or matching placebo |
| Cohort 3 | Experimental | Drug: GS-6615, Drug: PlaceboRandomized to 20 mg once daily (Days 1-7) followed by 9 mg once daily (Days 8-21) of GS-6615 or matching placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Weight of at least 50 kg with body mass index (BMI) between 18 and 30 kg/m2
- Female subjects must be of non-childbearing potential as defined per the protocol
- Male subjects with female partners of childbearing potential must be using protocol acceptable methods of contraception
- Willing and able to comply with the requirements of the protocol and directions
- Willing to avoid consumption of grapefruit, grapefruit juice and Seville oranges
Key exclusion criteria (13 listed)
- Ongoing or history of any medical or surgical condition that, in the judgment of the Investigator, might jeopardize the subject's safety or interfere with the study objectives
- History of meningitis or encephalitis, seizures, migraines, tremors, myoclonic jerks, sleep disorder, anxiety, syncope, head injuries or a family history of seizures
- Any abnormal ECG findings, abnormal laboratory value, or physical examination findings at Screening judged to be clinically significant
- Any abnormal neurological examination findings at Screening that is judged as clinically significant
- Hemoglobin < 12 g/dL
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-6615GS-6615 tablet(s) administered orally once daily | Drug | Cohort 1, Cohort 2, Cohort 3 |
| PlaceboPlacebo tablet(s) to match GS-6615 administered orally once daily | Drug | Cohort 1, Cohort 2, Cohort 3 |
Primary outcome
Safety and tolerability of GS-6615
Time frame: Up to 65 days
The primary outcome measure is the safety and tolerability of GS-6615 including neurological findings, adverse events, clinical laboratory tests, vital signs and ECG data (PR, RR, QRS, QT, and QTc [Fridericia] interval).
Pharmacokinetic (PK) profile of GS-6615
Time frame: Up to 65 days
The primary outcome measure is the PK profile of GS-6615 which will be measured with Cmax, Tmax, AUCtau, AUC0-∞, T1/2, CL/F, VSS/F, and R.
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 13 Nov 2013.
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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.
Elizabeth Layug, 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-6615 in people with Ischemic Heart Disease, run by Gilead Sciences 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 6 inclusion and 13 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 13 Nov 2013. 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. 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?
Safety and tolerability of GS-6615 (time frame: Up to 65 days). 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 13 Nov 2013.