A Phase 1 Study of Novel GS-9973 Tablet Formulations to Evaluate the Effect of Acid Reducing Agents, Relative Bioavailability, and Food Effect on GS-9973 Pharmacokinetics

February 5, 2014 updated by: Gilead Sciences

A Phase 1, Open-Label, Adaptive Study of Novel GS-9973 Tablet Formulations to Evaluate the Effect of Acid Reducing Agents, Relative Bioavailability, and Food Effect on GS-9973 Pharmacokinetics

This is a Phase 1, Open-Label, Adaptive Study of Novel GS-9973 Tablet Formulations to Evaluate the Effect of Acid Reducing Agents, Relative Bioavailability, and Food Effect on GS-9973 Pharmacokinetics.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
56

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Daytona Beach, Florida, United States, 32117
        • Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Have the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures
  • Must have a body mass index (BMI) range of approximately 19 to 30 kg/m2
  • Must have a minimum weight of 45 kg

  • Females of childbearing potential must have negative serum pregnancy tests at screening and baseline and must practice at least 1 reliable method of contraception as defined by the protocol

    • Female subjects who utilize hormonal contraceptive as 1 of their birth control methods must have used the same method for at least 3 months prior to study dosing
  • Male subjects must agree to use condoms during heterosexual intercourse and avoid sperm donation from Day -1 until 90 days following the last dose of study medication
  • Must refrain from blood donation throughout the study period
  • Must, in the opinion of the Investigator, be in good general
  • Must be a non- or light smoker, eg, less than 10 cigarettes per day

Exclusion Criteria:

  • Pregnant or lactating subjects
  • Use of prescribed or over-the-counter medications that affect gastric pH
  • History of severe peptic ulcer disease, GERD, or other diseases requiring prolonged(>6 weeks) medication or surgical therapy to modify gastric pH
  • Have a history of clinically significant cardiac abnormalities or presence of clinically significant abnormality on 12-lead ECG.
  • Have a history of any cancer requiring systemic chemotherapy or radiation
  • Have a history of bleeding disorders
  • Have a history of liver disorders
  • Current acute infection or history of acute infection within 7 days
  • Have a recent history of alcohol or illicit drug abuse and/or have a positive test for selected drugs of abuse
  • Have a positive hepatitis screen or positive Human Immunodeficiency Virus antibody test
  • Have participated in another clinical trial within 28 days
  • Have received transfusion of blood or plasma products within 6 months
  • Have donated > 500 mL blood within 56 days
  • Are unable or unwilling to comply with study restrictions, return for follow-up appointments, or other considerations, which in the opinion of the Investigator, would make the candidate unsuitable for study participation
  • Current or historical medical condition that is deemed to be of medical significance by the Investigator
  • Have used prescription medications, over the counter products, herbal remedies and nutritional supplements within 7 days

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Sequence 1
Drug: Treatment A
1600 mg GS-9973 (Formulation 1)
Drug: Treatment B
1600 mg GS-9973 (Formulation 1) plus 20 mg omeprazole
Drug: Treatment G
1600 mg GS-9973 (Reference formulation)
Drug: Treatment I
An alternate dose of the chosen formulation from Part A up to 1200 mg administered twice-daily
Experimental: Sequence 2
Drug: Treatment A
1600 mg GS-9973 (Formulation 1)
Drug: Treatment C
1600 mg GS-9973 (Formulation 1) plus 40 mg famotidine
Drug: Treatment H
1600 mg GS-9973 (Formulation 1 or Formulation 2, based on results from Part A)
Drug: Treatment J
An alternate dose of the chosen formulation from Part A up to 1200 mg administered twice-daily
Experimental: Sequence 3
Drug: Treatment G
1600 mg GS-9973 (Reference formulation)
Drug: Treatment I
An alternate dose of the chosen formulation from Part A up to 1200 mg administered twice-daily
Drug: Treatment D
1600 mg GS-9973 (Formulation 2)
Drug: Treatment E
1600 mg GS-9973 (Formulation 2) plus 20 mg omeprazole
Experimental: Sequence 4
Drug: Treatment H
1600 mg GS-9973 (Formulation 1 or Formulation 2, based on results from Part A)
Drug: Treatment J
An alternate dose of the chosen formulation from Part A up to 1200 mg administered twice-daily
Drug: Treatment D
1600 mg GS-9973 (Formulation 2)
Drug: Treatment F
1600 mg GS-9973 (Formulation 2) plus 40 mg famotidine

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pharmacokinetic parameters for GS-9973
Time Frame: Up to 3 months
The primary outcome measure is the pharmacokinetic (PK) parameters for GS-9973 including AUC and Cmax.
Up to 3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Secondary pharmacokinetic parameters for GS-9973
Time Frame: Up to 3 months
A secondary outcome measure is the pharmacokinetic parameters for GS-9973 including Ctau and AUClast.
Up to 3 months
Incidence of Adverse Events
Time Frame: Up to 3 months
A secondary outcome measure is the safety and tolerability of GS-9973 which will be evaluated by the incidence of AEs including assessment of clinical laboratory test findings, physical examinations, 12-lead ECG abnormalities, and vital signs measurements.
Up to 3 months
Blood PD parameters for GS-9973
Time Frame: Up to 3 months
A secondary outcome measure is the blood pharmacodynamic parameters.
Up to 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Gilead Sciences

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Michael Hawkins, MD, Gilead Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 24, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 24, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 26, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 7, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 5, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GS-US-339-0111

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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