HealthyPhase 1NCT01398046
Effects of Gastric pH on the Pharmacokinetics of Dasatinib
A Phase 1 study testing Dasatinib, Dasatinib plus Rabeprazole and Dasatinib plus Rabeprazole AND Betaine Hydrochloride in people with Healthy, run by University of California, San Francisco at 1 site in United States.
Trial summary
The goal of this study is to evaluate the ability of a natural supplement (betaine hydrochloride) to affect the absorption of dasatinib in healthy volunteers. The investigators predict that betaine hydrochloride will increase the absorption of dasatinib, in volunteers pre-treated with proton-pump inhibitors (PPIs). Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Dasatinib, Dasatinib plus Rabeprazole and Dasatinib plus Rabeprazole AND Betaine Hydrochloride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to Feb 2014
- 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 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female 18-59 years of age
- Healthy adult with no active medical problems or significant chronic diseases as determined by the study doctor based on history, physical exam and laboratory evaluations
- BMI between 18.5-30 kg/m2
- Taking no medications 2 weeks before and during the study enrollment, including drugs of abuse, prescription or over-the-counter (OTC) medications (except acetaminophen)
- Subjects able to maintain adequate birth control during the study independent of hormonal contraceptive use
- Be able to provide written informed consent and comply with requirements of the study
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- Avoid eating grapefruit and drinking grapefruit juice from 7 days before the first study day until the completion of the entire study
- Abstinence from alcoholic beverages, caffeinated beverages and orange juice from 3pm the night before a study day until completion of that study day
- Fast from food and beverages at least 8 hours prior to medication dosing
- Be able to read, speak, and understand English
Who cannot join
- Subjects with a history of gastrointestinal disease including gastroesophageal reflux disease, gastritis, peptic ulcer disease, or dyspepsia
- Subjects with a fasting gastric pH of > 4 (i.e. hypochlorhydria)
- Subjects with a history of dysphagia, achalasia, or difficulty swallowing capsules, tablets, or pills
- Subjects on prescription or chronic over-the-counter (OTC) medications (including hormonal contraceptives)
- Subjects with known allergies to rabeprazole or any other proton pump inhibitors (PPI's) or betaine hydrochloride
- Subjects who smoke tobacco
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- Subjects with ongoing alcohol or illegal drug use
- Subjects who are pregnant, lactating, or attempting to conceive
- Subjects unable to maintain adequate birth control during the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical Research Center, UCSF
San Francisco, California, 94143
About this study
Official title: Effects of Gastric pH on the Pharmacokinetics of Dasatinib in Healthy Volunteers
The goal of this study is to evaluate the ability of a natural supplement (betaine hydrochloride) to affect the absorption of dasatinib in healthy volunteers. The investigators predict that betaine hydrochloride will increase the absorption of dasatinib, in volunteers pre-treated with proton-pump inhibitors (PPIs).
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DasatinibDrug
dasatinib (100mg) PO x1
Dasatinib plus RabeprazoleDrug
Rabeprazole (20mg) PO twice daily (Days 1-3); Dasatinib (100mg) PO x1 (Day 4)
Dasatinib plus Rabeprazole AND Betaine HydrochlorideDrug
Rabeprazole (20mg) PO twice daily (Days 1-3); Betaine Hydrochloride (1500mg) PO x1 AND Dasatinib (100mg) PO x1 on Day 4
| Study group | Role | What they receive |
|---|---|---|
| Dasatinib | Active comparator | Not described Receives: Drug: Dasatinib |
| Dasatinib plus Rabeprazole | Experimental | Not described Receives: Drug: Dasatinib plus Rabeprazole |
| Dasatinib plus Rabeprazole AND Betaine Hydrochloride | Experimental | Not described Receives: Drug: Dasatinib plus Rabeprazole AND Betaine Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area-Under-the Concentration Curve from zero-to-twenty two hours (AUC,0-22) of Dasatinib
The primary outcome measure will be dasatinib area-under-the-concentration curve (AUC) values from zero-to-twenty two (0-22) hours. Values from Experiemntal Arms of the study (Dasatinib plus Rabeprazole; Dasatinib plus Rabeprazole AND Betaine Hydrochloride) will be compared against the active comparator (dasatinib alone) and tested for statistical significance.
Measured: Day 4
Area-Under-the Concentration Curve from zero-to-infinity (AUC,0-inf) of Dasatinib
The primary outcome measure will be dasatinib area-under-the-concentration curve (AUC) values from zero-to-infinite time (0-inf). Values from Experiemntal Arms of the study (Dasatinib plus Rabeprazole; Dasatinib plus Rabeprazole AND Betaine Hydrochloride) will be compared against the active comparator (dasatinib alone) and tested for statistical significance.
Measured: Day 4
Secondary outcomes (1)
Maximum Concentration of Dasatinib
The maximum plasma concentration (Cmax) will also be measured. Values from Experiemntal Arms of the study (Dasatinib plus Rabeprazole; Dasatinib plus Rabeprazole AND Betaine Hydrochloride) will be compared against the active comparator (Dasatinib alone) and tested for statistical significance.
Measured: Day 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2011 (estimated)
- Study startAug 2011
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Sponsor
- Investigators
- Leslie Z Benet, Ph.D, Principal investigator, University of California, San FranciscoLynda Frassetto, M.D., Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01398046
- Sponsor's protocol ID
- Dasatinib-63-03
- Status last verified
- Apr 2015
- First submitted
- 5 Jul 2011
- Last updated
- 28 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Yago MR, Frymoyer AR, Smelick GS, Frassetto LA, Budha NR, Dresser MJ, Ware JA, Benet LZ. Gastric reacidification with betaine HCl in healthy volunteers with rabeprazole-induced hypochlorhydria. Mol Pharm. 2013 Nov 4;10(11):4032-7. doi: 10.1021/mp4003738. Epub 2013 Sep 10.
PubMed 23980906
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Gastric pH on the Pharmacokinetics of Dasatinib in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01398046
- Acronym / sponsor ID
- Dasatinib-63-03
- Conditions
- Healthy
- Keywords
- dasatinib, betaine, betaine hydrochloride, pharmacokinetics, healthy volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- Aug 2011
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 20 Jul 2011 (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.
The goal of this study is to evaluate the ability of a natural supplement (betaine hydrochloride) to affect the absorption of dasatinib in healthy volunteers. The investigators predict that betaine hydrochloride will increase the absorption of dasatinib, in volunteers pre-treated with proton-pump inhibitors (PPIs).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dasatinib | Active comparator | Drug: Dasatinib |
| Dasatinib plus Rabeprazole | Experimental | Drug: Dasatinib plus Rabeprazole |
| Dasatinib plus Rabeprazole AND Betaine Hydrochloride | Experimental | Drug: Dasatinib plus Rabeprazole AND Betaine Hydrochloride |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Male or female 18-59 years of age
- Healthy adult with no active medical problems or significant chronic diseases as determined by the study doctor based on history, physical exam and laboratory evaluations
- BMI between 18.5-30 kg/m2
- Taking no medications 2 weeks before and during the study enrollment, including drugs of abuse, prescription or over-the-counter (OTC) medications (except acetaminophen)
- Subjects able to maintain adequate birth control during the study independent of hormonal contraceptive use
Key exclusion criteria (9 listed)
- Subjects with a history of gastrointestinal disease including gastroesophageal reflux disease, gastritis, peptic ulcer disease, or dyspepsia
- Subjects with a fasting gastric pH of > 4 (i.e. hypochlorhydria)
- Subjects with a history of dysphagia, achalasia, or difficulty swallowing capsules, tablets, or pills
- Subjects on prescription or chronic over-the-counter (OTC) medications (including hormonal contraceptives)
- Subjects with known allergies to rabeprazole or any other proton pump inhibitors (PPI's) or betaine hydrochloride
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 |
|---|---|---|
| Dasatinibdasatinib (100mg) PO x1 | Drug | Dasatinib |
| Dasatinib plus RabeprazoleRabeprazole (20mg) PO twice daily (Days 1-3); Dasatinib (100mg) PO x1 (Day 4) | Drug | Dasatinib plus Rabeprazole |
| Dasatinib plus Rabeprazole AND Betaine HydrochlorideRabeprazole (20mg) PO twice daily (Days 1-3); Betaine Hydrochloride (1500mg) PO x1 AND Dasatinib (100mg) PO x1 on Day 4 | Drug | Dasatinib plus Rabeprazole AND Betaine Hydrochloride |
Primary outcome
Area-Under-the Concentration Curve from zero-to-twenty two hours (AUC,0-22) of Dasatinib
Time frame: Day 4
The primary outcome measure will be dasatinib area-under-the-concentration curve (AUC) values from zero-to-twenty two (0-22) hours. Values from Experiemntal Arms of the study (Dasatinib plus Rabeprazole; Dasatinib plus Rabeprazole AND Betaine Hydrochloride) will be compared against the active comparator (dasatinib alone) and tested for statistical significance.
Area-Under-the Concentration Curve from zero-to-infinity (AUC,0-inf) of Dasatinib
Time frame: Day 4
The primary outcome measure will be dasatinib area-under-the-concentration curve (AUC) values from zero-to-infinite time (0-inf). Values from Experiemntal Arms of the study (Dasatinib plus Rabeprazole; Dasatinib plus Rabeprazole AND Betaine Hydrochloride) will be compared against the active comparator (dasatinib alone) and tested for statistical significance.
1 secondary outcome
Maximum Concentration of Dasatinib
Time frame: Day 4
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 28 Apr 2015.
- Derived from this study: PubMed 23980906Yago MR, Frymoyer AR, Smelick GS, Frassetto LA, Budha NR, Dresser MJ, Ware JA, Benet LZ. Gastric reacidification with betaine HCl in healthy volunteers with rabeprazole-induced hypochlorhydria. Mol Pharm. 2013 Nov 4;10(11):4032-7. doi: 10.1021/mp4003738. Epub 2013 Sep 10.
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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.
Leslie Z Benet, Ph.D principal investigator
University of California, San Francisco
Lynda Frassetto, M.D. principal investigator
University of California, San Francisco
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 Dasatinib, Dasatinib plus Rabeprazole and Dasatinib plus Rabeprazole AND Betaine Hydrochloride in people with Healthy, run by University of California, San Francisco 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 10 inclusion and 9 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 28 Apr 2015. 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?
Area-Under-the Concentration Curve from zero-to-twenty two hours (AUC,0-22) of Dasatinib (time frame: Day 4). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01398046, which also lists 1 linked publication.
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 28 Apr 2015.