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Completed

NCT Number: NCT01841489

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

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.

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Treatment A

Drug

1600 mg GS-9973 (Formulation 1)

Treatment B

Drug

1600 mg GS-9973 (Formulation 1) plus 20 mg omeprazole

Treatment C

Drug

1600 mg GS-9973 (Formulation 1) plus 40 mg famotidine

Treatment D

Drug

1600 mg GS-9973 (Formulation 2)

Treatment E

Drug

1600 mg GS-9973 (Formulation 2) plus 20 mg omeprazole

Treatment F

Drug

1600 mg GS-9973 (Formulation 2) plus 40 mg famotidine

Treatment G

Drug

1600 mg GS-9973 (Reference formulation)

Treatment H

Drug

1600 mg GS-9973 (Formulation 1 or Formulation 2, based on results from Part A)

Treatment I

Drug

An alternate dose of the chosen formulation from Part A up to 1200 mg administered twice-daily

Treatment J

Drug

An alternate dose of the chosen formulation from Part A up to 1200 mg administered twice-daily

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. Blood PD parameters for GS-9973

    Time frame: Up to 3 months

    A secondary outcome measure is the blood pharmacodynamic parameters.

Sponsors and collaborators

Lead sponsor

Gilead Sciences

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Apr 26, 2013
Registry last updated
Feb 7, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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