Healthy, no Evidence of DiseasePhase 1NCT00896207
Studying Different Formulations of SR13668 in Healthy Volunteers
A Phase 1 study testing Akt inhibitor SR13668 in people with Healthy, no Evidence of Disease, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
This randomized early phase I trial is studying different formulations of SR13668 in healthy volunteers. Giving SR13668 may help doctors learn more about how SR13668 is used by the body. It is not yet known which formulation of SR13668 is most effectively used by the body. Read more about this study
- Who is it for?
- Ages 18 to 62 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, no Evidence of Disease
- What is being tested?
- Akt inhibitor SR13668
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to Mar 2010
- 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 62 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteer
- ECOG performance status 0
- Leukocyte count ≥ 3,000/mm^3
- ANC ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Hemoglobin normal
Show all 38Show fewer
- Alkaline phosphatase ≤ 1.5 times upper limit of normal (ULN)
- ALT ≤ 1.5 times ULN
- Direct bilirubin ≤ 1.5 times ULN
- Sodium ≤ 1.5 times ULN
- Potassium ≤ 1.5 times ULN
- Creatinine ≤ 1.5 times ULN OR calculated creatinine clearance ≥ 30 mL/min
- Fasting blood glucose normal
- Not pregnant or nursing
- Negative pregnancy test
- Fertile participants must use effective barrier contraception
- Able and willing to fast overnight prior to study drug administration AND consume a high-fat meal on the day of study drug administration
- Willing to provide required blood and urine samples AND stay all day and overnight in the Clinical Research Unit
- Willing to abstain from alcoholic beverages and caffeine for ≥ 24 hours prior to study drug administration and until all blood and urine samples have been collected
- No cancer within the past 3 years except for nonmelanoma skin cancer, localized prostate cancer, superficial bladder cancer, or carcinoma in situ of the cervix
- No concurrent uncontrolled illness including, but not limited to, any of the following:
- Ongoing or active infection
- Symptomatic congestive heart failure
- Unstable angina pectoris
- Cardiac arrhythmia
- Severe chronic obstructive pulmonary disease requiring supplemental oxygen
- Hypertension that is difficult to control
- Psychiatric illness or social situation that would limit compliance with study requirements
- No diabetes mellitus
- No other condition that may, in the investigator's opinion, interfere with ingestion or absorption of oral medications (e.g., inflammatory bowel disease)
- No history of allergic-type reactions, including asthma and urticaria, or other intolerance to chemical compounds similar to the active study agent, indole-3-carbinol, or cruciferous vegetables (e.g., cabbage, cauliflower, broccoli, kale, and Brussels sprouts)
- More than 6 months since prior investigational agents
- More than 3 months since prior oral contraceptives (including Plan B method of contraception)
- No concurrent hormonal contraception
- More than 14 days since prior and no concurrent anticoagulant or antiplatelet medications
- More than 7 days since prior and no concurrent daily medications or nutritional supplements
- No prior gastrectomy that may, in the investigator's opinion, interfere with ingestion or absorption of oral medications
- No other concurrent medications
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single-Dose Phase 0 Exploratory Pharmacokinetic Clinical Trial Comparing Five Oral Formulations of SR13668, an Orally Active AKT Pathway Inhibitor
This randomized early phase I trial is studying different formulations of SR13668 in healthy volunteers. Giving SR13668 may help doctors learn more about how SR13668 is used by the body. It is not yet known which formulation of SR13668 is most effectively used by the body.
Read the detailed description
PRIMARY OBJECTIVES:
- Determine which oral formulation of Akt inhibitor SR13668 provides the best bioavailability in normal, healthy volunteers.
SECONDARY OBJECTIVES:
- Determine the oral pharmacokinetics of a single, low dose of Akt inhibitor SR13668 in healthy volunteers.
II. Characterize the metabolism of Akt inhibitor SR13668 in healthy volunteers. III. Collect preliminary safety data for Akt inhibitor SR13668 in healthy volunteers.
OUTLINE:
STAGE 1 (for the first 6 participants enrolled in the study [closed to accrual as of August, 2009]): Participants are randomized to 1 of 2 arms.
ARM I: Participants complete an overnight fast of ≥ 10 hours, eat a high-fat (approximately 50% of total caloric content of the meal) and high-calorie (approximately 800-1,000 calories), and then receive a single dose of oral SR13668 in a PEG400/Labrasol® liquid formulation with 8 ounces of water. Participants may not eat for ≥ 4 hours after study drug administration.
ARM II: Participants complete an overnight fast of ≥ 10 hours and then receive a single dose of oral SR13668 in a PEG400/Labrasol® liquid formulation with 8 ounces of water. Participants may not eat for ≥ 4 hours after study drug administration.
STAGE 2 (for the next 12 participants enrolled in the study): The preferred dietary condition (Arm I) identified in stage 1 is used. Participants are randomized to 1 of 4 arms.
ARM III: Participants receive a single dose of oral Akt inhibitor SR13668 in a Solutol® self-emulsifying solid dispersion capsule formulation.
ARM IV: Participants receive a single dose of oral Akt inhibitor SR13668 in a Solutol®/vitamin E TGPS self-emulsifying solid dispersion capsule formulation.
ARM V: Participants receive a single dose of oral Akt inhibitor SR13668 in a vitamin E TGPS self-emulsifying solid dispersion capsule formulation.
ARM VI: Participants receive a single dose of oral Akt inhibitor SR13668 in a Myrj 53 self-emulsifying solid dispersion capsule formulation.
Blood and urine samples are collected at baseline and periodically during the 24 hours after study drug administration for pharmacokinetic analysis by high performance liquid chromatography assay.
After completion of study treatment, participants are followed by telephone at 7-10 days and at 30 days.
- Conditions
- Healthy, no Evidence of Disease
- Being tested
- Akt inhibitor SR13668
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Akt inhibitor SR13668Drug
Also called SRI13668
Given orally as a single dose
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Experimental | Participants complete an overnight fast of ≥ 10 hours, eat a high-fat (approximately 50% of total caloric content of the meal) and high-calorie (approximately 800-1,000 calories) meal, and then receive a single dose of oral SR13668 in a PEG400/Labrasol® liquid formulation with 8 ounces of water. Participants may not eat for ≥ 4 hours after study drug administration. Receives: Drug: Akt inhibitor SR13668 |
| Arm II | Experimental | Participants complete an overnight fast of ≥ 10 hours and then receive a single dose of oral SR13668 in a PEG400/Labrasol® liquid formulation with 8 ounces of water. Participants may not eat for ≥ 4 hours after study drug administration. Receives: Drug: Akt inhibitor SR13668 |
| Arm III | Experimental | Participants receive a single dose of oral Akt inhibitor SR13668 in a Solutol® self-emulsifying solid dispersion capsule formulation. Receives: Drug: Akt inhibitor SR13668 |
| Arm IV | Experimental | Participants receive a single dose of oral Akt inhibitor SR13668 in a Solutol®/vitamin E TGPS self-emulsifying solid dispersion capsule formulation. Receives: Drug: Akt inhibitor SR13668 |
| Arm V | Experimental | Participants receive a single dose of oral Akt inhibitor SR13668 in a vitamin E TGPS self-emulsifying solid dispersion capsule formulation. Receives: Drug: Akt inhibitor SR13668 |
| Arm VI | Experimental | Participants receive a single dose of oral Akt inhibitor SR13668 in a Myrj 53 self-emulsifying solid dispersion capsule formulation. Receives: Drug: Akt inhibitor SR13668 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Food effect on the bioavailability of SR13668 after oral administration
The first stage will be used to compare fed vs. fasted diet effect on the pharmacokinetics parameters under formulation 1.
Measured: Up to 30 days after completion of study treatment
Formulation effect on the bioavailability of SR13668 after oral administration
The second stage will be used to determine the formulation effects on the pharmacokinetics parameters, all under either fed or fasted diet as determined by the first stage.
Measured: Up to 30 days after completion of study treatment
Secondary outcomes (4)
Solubility and stability of Akt inhibitor SR13668 in oral formulations selected for exploratory pharmacokinetics studies
Measured: Up to 30 days after completion of study treatment
Oral pharmacokinetics of a single low dose of Akt inhibitor SR13668
Measured: Up to 30 days after completion of study treatment
Metabolism of Akt inhibitor SR13668
Measured: Up to 30 days after completion of study treatment
Preliminary safety data for Akt inhibitor SR13668, graded according to NCI CTCAE version 3.0
Measured: Up to 30 days after completion of study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2009 (estimated)
- Study startJun 2009
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy, no Evidence of DiseaseStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Paul Limburg, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00896207
- Sponsor's protocol ID
- NCI-2009-01106
- Other IDs
- NCI-2009-01106, MAYO-MAY07-9-01, CDR0000638390, MAY-07-9-01, MAYO-MAY07-9-01, MAY07-9-01, P30CA015083
- Status last verified
- Oct 2011
- First submitted
- 8 May 2009
- Last updated
- 8 Oct 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-Dose Phase 0 Exploratory Pharmacokinetic Clinical Trial Comparing Five Oral Formulations of SR13668, an Orally Active AKT Pathway Inhibitor
- ClinicalTrials.gov ID
- NCT00896207
- Acronym / sponsor ID
- NCI-2009-01106
- Conditions
- Healthy, no Evidence of Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Jun 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 11 May 2009 (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 randomized early phase I trial is studying different formulations of SR13668 in healthy volunteers. Giving SR13668 may help doctors learn more about how SR13668 is used by the body. It is not yet known which formulation of SR13668 is most effectively used by the body.
Detailed description
PRIMARY OBJECTIVES:
- Determine which oral formulation of Akt inhibitor SR13668 provides the best bioavailability in normal, healthy volunteers.
SECONDARY OBJECTIVES:
- Determine the oral pharmacokinetics of a single, low dose of Akt inhibitor SR13668 in healthy volunteers.
II. Characterize the metabolism of Akt inhibitor SR13668 in healthy volunteers. III. Collect preliminary safety data for Akt inhibitor SR13668 in healthy volunteers.
OUTLINE:
STAGE 1 (for the first 6 participants enrolled in the study [closed to accrual as of August, 2009]): Participants are randomized to 1 of 2 arms.
ARM I: Participants complete an overnight fast of ≥ 10 hours, eat a high-fat (approximately 50% of total caloric content of the meal) and high-calorie (approximately 800-1,000 calories), and then receive a single dose of oral SR13668 in a PEG400/Labrasol® liquid formulation with 8 ounces of water. Participants may not eat for ≥ 4 hours after study drug administration.
ARM II: Participants complete an overnight fast of ≥ 10 hours and then receive a single dose of oral SR13668 in a PEG400/Labrasol® liquid formulation with 8 ounces of water. Participants may not eat for ≥ 4 hours after study drug administration.
STAGE 2 (for the next 12 participants enrolled in the study): The preferred dietary condition (Arm I) identified in stage 1 is used. Participants are randomized to 1 of 4 arms.
ARM III: Participants receive a single dose of oral Akt inhibitor SR13668 in a Solutol® self-emulsifying solid dispersion capsule formulation.
ARM IV: Participants receive a single dose of oral Akt inhibitor SR13668 in a Solutol®/vitamin E TGPS self-emulsifying solid dispersion capsule formulation.
ARM V: Participants receive a single dose of oral Akt inhibitor SR13668 in a vitamin E TGPS self-emulsifying solid dispersion capsule formulation.
ARM VI: Participants receive a single dose of oral Akt inhibitor SR13668 in a Myrj 53 self-emulsifying solid dispersion capsule formulation.
Blood and urine samples are collected at baseline and periodically during the 24 hours after study drug administration for pharmacokinetic analysis by high performance liquid chromatography assay.
After completion of study treatment, participants are followed by telephone at 7-10 days and at 30 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Arm I | Experimental | Drug: Akt inhibitor SR13668Participants complete an overnight fast of ≥ 10 hours, eat a high-fat (approximately 50% of total caloric content of the meal) and high-calorie (approximately 800-1,000 calories) meal, and then receive a single dose of oral SR13668 in a PEG400/Labrasol® liquid formulation with 8 ounces of water. Participants may not eat for ≥ 4 hours after study drug administration. |
| Arm II | Experimental | Drug: Akt inhibitor SR13668Participants complete an overnight fast of ≥ 10 hours and then receive a single dose of oral SR13668 in a PEG400/Labrasol® liquid formulation with 8 ounces of water. Participants may not eat for ≥ 4 hours after study drug administration. |
| Arm III | Experimental | Drug: Akt inhibitor SR13668Participants receive a single dose of oral Akt inhibitor SR13668 in a Solutol® self-emulsifying solid dispersion capsule formulation. |
| Arm IV | Experimental | Drug: Akt inhibitor SR13668Participants receive a single dose of oral Akt inhibitor SR13668 in a Solutol®/vitamin E TGPS self-emulsifying solid dispersion capsule formulation. |
| Arm V | Experimental | Drug: Akt inhibitor SR13668Participants receive a single dose of oral Akt inhibitor SR13668 in a vitamin E TGPS self-emulsifying solid dispersion capsule formulation. |
| Arm VI | Experimental | Drug: Akt inhibitor SR13668Participants receive a single dose of oral Akt inhibitor SR13668 in a Myrj 53 self-emulsifying solid dispersion capsule formulation. |
Who may qualify
- Ages
- 18 to 62 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (38 listed)
- Healthy volunteer
- ECOG performance status 0
- Leukocyte count ≥ 3,000/mm^3
- ANC ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Akt inhibitor SR13668Also: SRI13668Given orally as a single dose | Drug | Arm I, Arm II, Arm III, Arm IV, Arm V, Arm VI |
Primary outcome
Food effect on the bioavailability of SR13668 after oral administration
Time frame: Up to 30 days after completion of study treatment
The first stage will be used to compare fed vs. fasted diet effect on the pharmacokinetics parameters under formulation 1.
Formulation effect on the bioavailability of SR13668 after oral administration
Time frame: Up to 30 days after completion of study treatment
The second stage will be used to determine the formulation effects on the pharmacokinetics parameters, all under either fed or fasted diet as determined by the first stage.
4 secondary outcomes
Solubility and stability of Akt inhibitor SR13668 in oral formulations selected for exploratory pharmacokinetics studies
Time frame: Up to 30 days after completion of study treatment
Oral pharmacokinetics of a single low dose of Akt inhibitor SR13668
Time frame: Up to 30 days after completion of study treatment
Metabolism of Akt inhibitor SR13668
Time frame: Up to 30 days after completion of study treatment
Preliminary safety data for Akt inhibitor SR13668, graded according to NCI CTCAE version 3.0
Time frame: Up to 30 days after completion of study treatment
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 8 Oct 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.
Paul Limburg principal investigator
Mayo Clinic
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 Akt inhibitor SR13668 in people with Healthy, no Evidence of Disease, run by National Cancer Institute (NCI) 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 38 inclusion and 0 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 8 Oct 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?
Food effect on the bioavailability of SR13668 after oral administration (time frame: Up to 30 days after completion of study treatment). 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?
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 8 Oct 2014.