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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

Information source: Gilead Sciences
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Chronic Lymphocytic Leukemia

Intervention: Treatment A (Drug); Treatment B (Drug); Treatment C (Drug); Treatment D (Drug); Treatment E (Drug); Treatment F (Drug); Treatment G (Drug); Treatment H (Drug); Treatment I (Drug); Treatment J (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Gilead Sciences

Official(s) and/or principal investigator(s):
Michael Hawkins, MD, Study Director, Affiliation: Gilead Sciences

Summary

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.

Clinical Details

Official 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

Study design: Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Pharmacokinetic parameters for GS-9973

Secondary outcome:

Secondary pharmacokinetic parameters for GS-9973

Incidence of Adverse Events

Blood PD parameters for GS-9973

Eligibility

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

Investigational Site, Daytona Beach, Florida 32117, United States
Additional Information

Starting date: May 2013
Last updated: February 5, 2014

Page last updated: August 23, 2015

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