Chronic Lymphocytic LeukemiaPhase 1NCT01841489
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
A Phase 1 study testing Treatment A, Treatment B and Treatment C in people with Chronic Lymphocytic Leukemia, run by Gilead Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Lymphocytic Leukemia
- What is being tested?
- Treatment A, Treatment B and Treatment C
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- May 2013to Oct 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Chronic Lymphocytic Leukemia
- Being tested
- Treatment A, Treatment B, Treatment C, Treatment D, Treatment E
- Keywords
- Chronic Lymphocytic Leukemia, CLL
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment ADrug
1600 mg GS-9973 (Formulation 1)
Treatment BDrug
1600 mg GS-9973 (Formulation 1) plus 20 mg omeprazole
Treatment CDrug
1600 mg GS-9973 (Formulation 1) plus 40 mg famotidine
Treatment DDrug
1600 mg GS-9973 (Formulation 2)
Treatment EDrug
1600 mg GS-9973 (Formulation 2) plus 20 mg omeprazole
Treatment FDrug
1600 mg GS-9973 (Formulation 2) plus 40 mg famotidine
Treatment GDrug
1600 mg GS-9973 (Reference formulation)
Treatment HDrug
1600 mg GS-9973 (Formulation 1 or Formulation 2, based on results from Part A)
Treatment IDrug
An alternate dose of the chosen formulation from Part A up to 1200 mg administered twice-daily
Treatment JDrug
An alternate dose of the chosen formulation from Part A up to 1200 mg administered twice-daily
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1 | Experimental | Not described Receives: Drug: Treatment A; Drug: Treatment B; Drug: Treatment G; Drug: Treatment I |
| Sequence 2 | Experimental | Not described Receives: Drug: Treatment A; Drug: Treatment C; Drug: Treatment H; Drug: Treatment J |
| Sequence 3 | Experimental | Not described Receives: Drug: Treatment D; Drug: Treatment E; Drug: Treatment G; Drug: Treatment I |
| Sequence 4 | Experimental | Not described Receives: Drug: Treatment D; Drug: Treatment F; Drug: Treatment H; Drug: Treatment J |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic parameters for GS-9973
The primary outcome measure is the pharmacokinetic (PK) parameters for GS-9973 including AUC and Cmax.
Measured: Up to 3 months
Secondary outcomes (3)
Secondary pharmacokinetic parameters for GS-9973
A secondary outcome measure is the pharmacokinetic parameters for GS-9973 including Ctau and AUClast.
Measured: Up to 3 months
Incidence of Adverse Events
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.
Measured: Up to 3 months
Blood PD parameters for GS-9973
A secondary outcome measure is the blood pharmacodynamic parameters.
Measured: Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2013 (estimated)
- Study startMay 2013
- Primary completionAug 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Lymphocytic LeukemiaStudies of the same condition, open and under way.
- More trials run by Gilead SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Hawkins, MD, Study director, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01841489
- Sponsor's protocol ID
- GS-US-339-0111
- Status last verified
- Feb 2014
- First submitted
- 24 Apr 2013
- Last updated
- 7 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01841489
- Acronym / sponsor ID
- GS-US-339-0111
- Conditions
- Chronic Lymphocytic Leukemia
- Keywords
- Chronic Lymphocytic Leukemia, CLL
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- May 2013
- Primary completion
- Aug 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 26 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Sequence 1 | Experimental | Drug: Treatment A, Drug: Treatment B, Drug: Treatment G, Drug: Treatment I |
| Sequence 2 | Experimental | Drug: Treatment A, Drug: Treatment C, Drug: Treatment H, Drug: Treatment J |
| Sequence 3 | Experimental | Drug: Treatment D, Drug: Treatment E, Drug: Treatment G, Drug: Treatment I |
| Sequence 4 | Experimental | Drug: Treatment D, Drug: Treatment F, Drug: Treatment H, Drug: Treatment J |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment A1600 mg GS-9973 (Formulation 1) | Drug | Sequence 1, Sequence 2 |
| Treatment B1600 mg GS-9973 (Formulation 1) plus 20 mg omeprazole | Drug | Sequence 1 |
| Treatment C1600 mg GS-9973 (Formulation 1) plus 40 mg famotidine | Drug | Sequence 2 |
| Treatment D1600 mg GS-9973 (Formulation 2) | Drug | Sequence 3, Sequence 4 |
| Treatment E1600 mg GS-9973 (Formulation 2) plus 20 mg omeprazole | Drug | Sequence 3 |
| Treatment F1600 mg GS-9973 (Formulation 2) plus 40 mg famotidine | Drug | Sequence 4 |
| Treatment G1600 mg GS-9973 (Reference formulation) | Drug | Sequence 1, Sequence 3 |
| Treatment H1600 mg GS-9973 (Formulation 1 or Formulation 2, based on results from Part A) | Drug | Sequence 2, Sequence 4 |
| Treatment IAn alternate dose of the chosen formulation from Part A up to 1200 mg administered twice-daily | Drug | Sequence 1, Sequence 3 |
| Treatment JAn alternate dose of the chosen formulation from Part A up to 1200 mg administered twice-daily | Drug | Sequence 2, Sequence 4 |
Primary outcome
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.
3 secondary outcomes
Secondary pharmacokinetic parameters for GS-9973
Time frame: Up to 3 months
Incidence of Adverse Events
Time frame: Up to 3 months
Blood PD parameters for GS-9973
Time frame: Up to 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Hawkins, MD study director
Gilead Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Treatment A, Treatment B and Treatment C in people with Chronic Lymphocytic Leukemia, run by Gilead Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetic parameters for GS-9973 (time frame: Up to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2014.