A Phase 1 Study to Assess the Safety,Tolerability, and Pharmacokinetics of GS-6615 in Healthy Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01847391
First received: May 2, 2013
Last updated: November 11, 2013
Last verified: November 2013

May 2, 2013
November 11, 2013
May 2013
November 2013   (final data collection date for primary outcome measure)
  • Safety and tolerability of GS-6615 [ Time Frame: Up to 65 days ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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.
  • Safety and tolerability of GS-6615 [ Time Frame: Up to 65 days ] [ Designated as safety issue: Yes ]
    The primary outcome measure is the safety and tolerability of GS-6615 including neurological findings, AEs, clinical laboratory tests, vital signs and ECG data [PR, RR, QRS, QT and QTc (Fridericia) interval].
  • PK Profile of GS-6615 [ Time Frame: Up to 65 days ] [ Designated as safety issue: No ]
    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.
Complete list of historical versions of study NCT01847391 on ClinicalTrials.gov Archive Site
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A Phase 1 Study to Assess the Safety,Tolerability, and Pharmacokinetics of GS-6615 in Healthy Subjects
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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Ischemic Heart Disease
  • Drug: GS-6615
    GS-6615 tablet(s) administered orally once daily
  • Drug: Placebo
    Placebo tablet(s) to match GS-6615 administered orally once daily
  • Experimental: Cohort 1
    Randomized to 6 mg once daily (Days 1-7) followed by 3 mg once daily (Days 8-21) of GS-6615 or matching placebo
    Interventions:
    • Drug: GS-6615
    • Drug: Placebo
  • Experimental: Cohort 2
    Randomized to 12 mg once daily (Days 1-7) followed by 6 mg once daily (Days 8-21) of GS-6615 or matching placebo
    Interventions:
    • Drug: GS-6615
    • Drug: Placebo
  • Experimental: Cohort 3
    Randomized to 20 mg once daily (Days 1-7) followed by 9 mg once daily (Days 8-21) of GS-6615 or matching placebo
    Interventions:
    • Drug: GS-6615
    • Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
November 2013
November 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01847391
GS-US-279-0102
No
Gilead Sciences
Gilead Sciences
Not Provided
Study Director: Elizabeth Layug, MD Gilead Sciences
Gilead Sciences
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP