Ischemic Heart Disease
Conditions
Keywords
Ischemic Heart Disease, Heart Disease
Brief 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.
Interventions
DRUGGS-6615
GS-6615 tablet(s) administered orally once daily
DRUGPlacebo
Placebo tablet(s) to match GS-6615 administered orally once daily
Sponsors
Gilead Sciences
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and tolerability of GS-6615 | 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 | 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. |
Countries
United States
Outcome results
None listed