Drug InteractionPhase 1NCT04540965
Impact of a Histamine H2 Receptor Antagonist (H2RA) on the Pharmacokinetics (PK) of Telaglenastat in Healthy Subjects
A Phase 1 study testing Telaglenastat and Famotidine in people with Drug Interaction, run by Calithera Biosciences, Inc at 1 site in Australia.
Trial summary
This study is designed to formally evaluate the impact of famotidine, an H2R antagonist, on the pharmacokinetics of telaglenastat. This study will be conducted in up to 22 healthy volunteers, who meet all of the inclusion criteria and none of the exclusion criteria. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Drug Interaction
- What is being tested?
- Telaglenastat and Famotidine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteAustralia
- Study dates
- 22 Sep 2020to 8 Dec 2020
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult male or female, 18-55 years of age, inclusive, at screening.
- Has not used nicotine-containing products (more than 5 cigarettes/equivalent per week) for at least 3 months prior the first dose and has negative urine cotinine tests at screening, Day 1 and Day 7.
- Body mass index (BMI) between 18.0 and 32.0 kg/m2, inclusively, at screening.
- Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs, or ECGs, as deemed by the Principal Investigator (PI).
- For a female of childbearing potential: either be sexually inactive (abstinent - ie, not sexually active with a male partner) for 14 days prior to the first dose and through 14 days following the last dose of any study drug(s) or be using one of the following acceptable birth control methods:
- Non-hormone releasing intrauterine device in place for at least 3 months prior to the first dose of any study drug with a physical barrier method (eg, condom, diaphragm) from the time of screening through the last dose of any study drug. A progesterone (progestin)-only contraceptive is allowable.
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- A physical barrier method (eg, condom, diaphragm) for at least 14 days prior to the first dose of any study drug and until the last dose of any study drug.
- In addition, female subjects of childbearing potential will be advised to remain sexually inactive or to keep the same birth control method until the last dose of any study drug.
- Females of non-childbearing potential as defined below do not require contraception.
- Females of non-childbearing potential:
- must have undergone one of the following sterilization procedures at least 6 months prior to the first dose of any study drug:
- hysteroscopic sterilization;
- bilateral salpingectomy;
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- Women with a tubal ligation less than one year prior to study start must agree to use a barrier method of birth control 3. non-surgical transcervical sterilization (eg, Essure®); 4. hysterectomy; 5. bilateral oophorectomy OR
- be postmenopausal with amenorrhea for at least 1 year prior to the first telaglenastat dose with follicle-stimulating hormone (FSH) serum levels > 30 IU/mL.
- A non-vasectomized male subject must agree to use a physical barrier (eg, condom or diaphragm) or abstain from sexual intercourse with female partners during the study until the last dose of any study drug. (No restrictions are required for a vasectomized male provided his vasectomy has been performed 4 months or more prior to study start. A male who has been vasectomized less than 4 months prior to study start must follow the same restrictions as a non-vasectomized male).
- Female participants with a vasectomized male partner, or male participants with a female partner of non-childbearing potential do not require contraception.
- If male, must agree not to donate sperm from dosing until the last dose of any study drug.
- Alanine and aspartate aminotransferase and bilirubin levels ≤ the upper limit of normal or deemed not clinically significant by the Investigator.
- Understands the study procedures in the informed consent form (ICF) and be willing and able to comply with the protocol.
Who cannot join
- Subject is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or is expected to manifest significant emotional problems during the conduct of the study.
- History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI.
- History of any illness that, in the opinion of the PI, might confound the results of the study or poses an additional risk to the subject by their participation in the study.
- History or presence of alcoholism or drug abuse within the past 2 years prior to screening.
- History or presence of hypersensitivity or idiosyncratic reaction to the study drugs or inactive ingredient(s).
- History or presence of:
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- liver disease, pancreatic insufficiency or intestinal malabsorption;
- neuropathy or muscle disorders;
- seizures;
- asthma; childhood asthma that has resolved and has not required medical treatment for at least 5 years prior to study start is permitted;
- fluid retention;
- cardiovascular disease, cardiac arrhythmias, hypertension, cardiovascular thrombotic events, myocardial infarction, or stroke;
- ulcer disease or gastrointestinal bleeding;
- renal papillary necrosis and other renal injury;
- exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis.
- Female subjects who are pregnant or lactating.
- Positive urine drug or alcohol results at screening or check-in.
- Positive urine cotinine at screening or check-in.
- Positive results at screening for HIV types 1 and 2, HBsAg, or hepatitus C virus.
- Seated blood pressure (taken after 5 minutes in a sitting position) is less than 90/40 mmHg or greater than 140/90 mmHg at screening and not as part of ECG.
- Seated heart rate (taken after 5 minutes in a sitting position) is lower than 40 bpm or higher than 100 bpm at screening and not as part of ECG.
- QTcF interval is > 460 msec (males) or > 480 msec (females) or deemed clinically abnormal by the PI at screening.
- Estimated creatinine clearance < 90 mL/min calculated by the method of Cockcroft and Gault at screening.
- Unable to refrain from or anticipates the use of:
- Proton pump inhibitors (PPIs), histamine H2 receptor antagonists (H2RAs), buffering agents (eg, Tums) or any other medication that may have an effect on gastric acid secretion beginning 14 days prior to the first dose of any study drug and throughout the study.
- Any non-prescription medications, herbal remedies, or vitamin supplements beginning 14 days prior to the first dose of any study drug and throughout the study.
- Any prescription medications (including hormone replacement therapy and lithium) beginning 14 days prior to the first dose of any study drug and throughout the study.
- Donation of blood or significant blood loss within 56 days prior to the first dose of any study drug.
- Plasma donation within 14 days prior to the first dose of any study drug.
- Presence of any medical history or condition that may limit gastric drug absorption (eg, prior gastric surgery, gastric banding, Whipple procedure)
- Participation in another clinical trial within 28 days prior to the first dose of any study drug. The 28-day window will be derived from the date of the last blood collection or dosing, whichever is later, in the previous study to Day 1 of Period 1 of the current study.
Trial locations and contacts
1 site in 1 country.
Australia1 site
Nucleus Network Brisbane Clinic (formerly Q-Pharm)
Brisbane, Queensland, Herston QLD 4006
About this study
Official title: Double-Blind, Randomized, 2-Way Crossover Evaluation of the Impact of a Histamine-H2 Receptor Antagonist (H2RA) on the Pharmacokinetics of Telaglenastat Administered to Healthy Adult Subjects
This study is designed to formally evaluate the impact of famotidine, an H2R antagonist, on the pharmacokinetics of telaglenastat.
This study will be conducted in up to 22 healthy volunteers, who meet all of the inclusion criteria and none of the exclusion criteria. The study is double-blinded, randomized 2-way crossover in design.
Subjects will receive four 200 mg tablets of telaglenastat either in the presence or absence of 20 mg famotidine (H2R-antagonist) with a 4-day wash-out period in between each regimen.
- Conditions
- Drug Interaction
- Being tested
- Telaglenastat, Famotidine, Placebo for famotidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelaglenastatDrug
Also called CB-839
Glutaminase inhibitor
FamotidineDrug
Also called Pepcid
Histamine-H2 Receptor Antagonist
Placebo for famotidineDrug
Placebo for Histamine-H2 Receptor Antagonist
| Study group | Role | What they receive |
|---|---|---|
| Telaglenastat and Famotidine | Experimental | Famotidine Receives: Drug: Telaglenastat; Drug: Famotidine |
| Telaglenastat and Placebo for Famotidine | Placebo comparator | Placebo for famotidine Receives: Drug: Telaglenastat; Drug: Placebo for famotidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Plasma Concentration (Cmax)
To assess the effect of famotidine on the Cmax of telaglenastat in healthy adult subjects
Measured: Blood samples taken on Day 3 and Day 9 at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 18, 24 hours post administration of the telaglenastat
Time to peak plasma concentration (Tmax)
To assess the effect of famotidine on the Tmax of telaglenastat in healthy adult subjects
Measured: Blood samples taken on Day 3 and Day 9 at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 18, 24 hours post administration of the telaglenastat
Area under the concentration-time curve from time = 0 to the last determination (AUClast)
To assess the effect of famotidine on the time to maximum plasma concentration (Tmax) of telaglenastat in healthy adult subjects.
Measured: Blood samples taken on Day 3 and Day 9 at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 18, 24 hours post administration of the telaglenastat with and without famotidine.
Area under the concentration-time curve from time = 0 to infinity (AUC0-inf)
To assess the effect of famotidine on the AUC0-inf of telaglenastat in healthy adult subjects
Measured: Blood samples taken on Day 3 and Day 9 at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 18, 24 hours post administration of the telaglenastat with and without famotidine.
Half-life
To assess the effect of famotidine on the half-life of telaglenastat in healthy adult subjects
Measured: Blood samples taken on Day 3 and Day 9 at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 18, 24 hours post administration of the telaglenastat with and without famotidine.
Elimination rate
To assess the effect of famotidine on the elimination rate of telaglenastat in healthy adult subjects
Measured: Blood samples taken on Day 3 and Day 9 at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 18, 24 hours post administration of the telaglenastat with and without famotidine.
Secondary outcomes (32)
Incidence of Treatment-Emergent Adverse Events
Assessed by physician reports of any unfavorable and unintended sign, symptom, or disease (new or exacerbated) that is temporally associated with the use of the investigational products.
Measured: Safety will be assessed throughout the study, starting from Day 3, prior to receiving the first dose of telaglenastat through to Day 11 when the subjects are released from the clinical site.
Incidence of changes in body temperature
Body temperature is measured in degrees Celsius.
Measured: Body temperature will be assessed prior to dosing with telaglenastat on Days 2 and 9 and 24 hours after dosing on Days 4 and 11.
Incidence of changes in respiratory rate.
Respiratory rate is measured in breaths per minute.
Measured: Respiratory rate will be assessed prior to dosing with telaglenastat on Days 2 and 9 and 24 hours after dosing on Days 4 and 11.
Incidence of changes in blood pressure
Blood pressure is measured in mmHg.
Measured: Blood pressure will be assessed prior to dosing with telaglenastat on Days 2 and 9 and 24 hours after dosing on Days 4 and 11.
Incidence of changes in heart rate.
Heart rate is measured in beats per minute.
Measured: Heart rate will be assessed prior to dosing with telaglenastat on Days 2 and 9 and 24 hours after dosing on Days 4 and 11.
Electrocardiograms (ECGs)
Triplicate 12-lead ECGs including P Wave, QRS Complex, and QTcF determination
Measured: ECGs will be performed prior to and 4 hours after telaglenastat dosing on Days 3 and 10 and 24 hours after telaglenastat dosing on Days 4 and 11.
Hemoglobin assessments
Hemoglobin will be measured in g/dL
Measured: Assessments will be performed prior to dosing with telaglenastat on Days 2 and 9 and 24 hours after dosing on Days 4 and 11.
Hematocrit assessments
Hematocrit will be measured in %
Measured: Assessments will be performed prior to dosing with telaglenastat on Days 2 and 9 and 24 hours after dosing on Days 4 and 11.
Leukocyte count assessments
Leukocyte count will be measured in 1000 cells/microliter
Measured: Assessments will be performed prior to dosing with telaglenastat on Days 2 and 9 and 24 hours after dosing on Days 4 and 11.
Red blood cell count assessments
Red blood cell count will be measured in 1,000,000 cells/microliter
Measured: Assessments will be performed prior to dosing with telaglenastat on Days 2 and 9 and 24 hours after dosing on Days 4 and 11.
Platelet count assessments
Platelet count.will be measured in 1000 cells/microliter
Measured: Assessments will be performed prior to dosing with telaglenastat on Days 2 and 9 and 24 hours after dosing on Days 4 and 11.
Serum urea
Serum Urea will be measured in mg/dL
Measured: Assessments will be performed prior to dosing with telaglenastat on Days 2 and 9 and 24 hours after dosing on Days 4 and 11.
Serum bilirubin
Serum Bilirubin will be measured in micromoles/L
Measured: Assessments will be performed prior to dosing with telaglenastat on Days 2 and 9 and 24 hours after dosing on Days 4 and 11.
Serum alkaline phosphatase
Serum alkaline phosphatase will be measured in units/L
Measured: Assessments will be performed prior to dosing with telaglenastat on Days 2 and 9 and 24 hours after dosing on Days 4 and 11.
Serum Aspartate aminotransferase assessments
Serum Aspartate aminotransferase will be measured in units/L
Measured: Assessments will be performed prior to dosing with telaglenastat on Days 2 and 9 and 24 hours after dosing on Days 4 and 11.
Serum aspartate aminotransferase
Serum Alanine aminotransferase will be measured in units/L
Measured: Assessments will be performed prior to dosing with telaglenastat on Days 2 and 9 and 24 hours after dosing on Days 4 and 11.
Serum albumin
Serum Albumin will be measured in g/dL
Measured: Assessments will be performed prior to dosing with telaglenastat on Days 2 and 9 and 24 hours after dosing on Days 4 and 11.
Serum sodium
Serum Sodium will be measured in meq/L
Measured: Assessments will be performed prior to dosing with telaglenastat on Days 2 and 9 and 24 hours after dosing on Days 4 and 11.
Serum potassium
Serum Potassium will be measured in meq/L
Measured: Assessments will be performed prior to dosing with telaglenastat on Days 2 and 9 and 24 hours after dosing on Days 4 and 11.
Serum chloride
Serum Chloride will be measured in meq/L
Measured: Assessments will be performed prior to dosing with telaglenastat on Days 2 and 9 and 24 hours after dosing on Days 4 and 11.
Serum glucose
Serum Glucose will be measured in mg/dL
Measured: Assessments will be performed prior to dosing with telaglenastat on Days 2 and 9 and 24 hours after dosing on Days 4 and 11.
Serum creatinine
Serum Creatinine will be measured in mg/dL
Measured: Assessments will be performed prior to dosing with telaglenastat on Days 2 and 9 and 24 hours after dosing on Days 4 and 11.
Urine pH
Urine pH will be measured in units
Measured: Assessments will be performed prior to dosing with telaglenastat on Days 2 and 9 and 24 hours after dosing on Days 4 and 11.
Urine Specific gravity
Urine Specific gravity will be measured in g/mL
Measured: Assessments will be performed prior to dosing with telaglenastat on Days 2 and 9 and 24 hours after dosing on Days 4 and 11.
Urine Protein
Urine Protein will be measured in mg/24 hr
Measured: Assessments will be performed prior to dosing with telaglenastat on Days 2 and 9 and 24 hours after dosing on Days 4 and 11.
Urine Glucose
Urine Glucose will be measured in mg/dL
Measured: Assessments will be performed prior to dosing with telaglenastat on Days 2 and 9 and 24 hours after dosing on Days 4 and 11.
Urine Ketones
Urine Ketones will be measured in mg/dL
Measured: Assessments will be performed prior to dosing with telaglenastat on Days 2 and 9 and 24 hours after dosing on Days 4 and 11.
Urine Bilirubin
Urine Bilirubin will be measured in mg/dL
Measured: Assessments will be performed prior to dosing with telaglenastat on Days 2 and 9 and 24 hours after dosing on Days 4 and 11.
Urine Blood
Urine Blood will be measured in RBC/high powered field
Measured: Assessments will be performed prior to dosing with telaglenastat on Days 2 and 9 and 24 hours after dosing on Days 4 and 11.
Urine Nitrite
Urine Nitrite will be measured by dipstick
Measured: Assessments will be performed prior to dosing with telaglenastat on Days 2 and 9 and 24 hours after dosing on Days 4 and 11.
Urine Urobilinogen
Urine Urobilinogen will be measured in Ehrlich units
Measured: Assessments will be performed prior to dosing with telaglenastat on Days 2 and 9 and 24 hours after dosing on Days 4 and 11.
Urine Leukocyte esterase.
Urine Leukocyte esterase will be measured in units
Measured: Assessments will be performed prior to dosing with telaglenastat on Days 2 and 9 and 24 hours after dosing on Days 4 and 11.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2020
- Study start22 Sep 2020
- Primary completion8 Dec 2020
- Study completion8 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug InteractionStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Calithera Biosciences, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Novotech (Australia) Pty Limited
- Responsible party
- Sponsor
- Investigators
- Paul Griffin, Dr., Principal investigator, Nucleus Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04540965
- Sponsor's protocol ID
- CX-839-015
- Status last verified
- Mar 2021
- First submitted
- 19 Aug 2020
- Last updated
- 9 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-Blind, Randomized, 2-Way Crossover Evaluation of the Impact of a Histamine-H2 Receptor Antagonist (H2RA) on the Pharmacokinetics of Telaglenastat Administered to Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT04540965
- Acronym / sponsor ID
- CX-839-015
- Conditions
- Drug Interaction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Calithera Biosciences, IncIndustry (pharma, biotech, devices)
- Collaborators
- Novotech (Australia) Pty Limited
- Study start
- 22 Sep 2020 (actual)
- Primary completion
- 8 Dec 2020 (actual)
- Study completion
- 8 Dec 2020 (actual)
- First posted
- 7 Sep 2020 (actual)
- 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 study is designed to formally evaluate the impact of famotidine, an H2R antagonist, on the pharmacokinetics of telaglenastat.
This study will be conducted in up to 22 healthy volunteers, who meet all of the inclusion criteria and none of the exclusion criteria. The study is double-blinded, randomized 2-way crossover in design.
Subjects will receive four 200 mg tablets of telaglenastat either in the presence or absence of 20 mg famotidine (H2R-antagonist) with a 4-day wash-out period in between each regimen.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telaglenastat and Famotidine | Experimental | Drug: Telaglenastat, Drug: FamotidineFamotidine |
| Telaglenastat and Placebo for Famotidine | Placebo comparator | Drug: Telaglenastat, Drug: Placebo for famotidinePlacebo for famotidine |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (21 listed)
- Healthy adult male or female, 18-55 years of age, inclusive, at screening.
- Has not used nicotine-containing products (more than 5 cigarettes/equivalent per week) for at least 3 months prior the first dose and has negative urine cotinine tests at screening, Day 1 and Day 7.
- Body mass index (BMI) between 18.0 and 32.0 kg/m2, inclusively, at screening.
- Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs, or ECGs, as deemed by the Principal Investigator (PI).
- For a female of childbearing potential: either be sexually inactive (abstinent - ie, not sexually active with a male partner) for 14 days prior to the first dose and through 14 days following the last dose of any study drug(s) or be using one of the following acceptable birth control methods:
Key exclusion criteria (31 listed)
- Subject is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or is expected to manifest significant emotional problems during the conduct of the study.
- History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI.
- History of any illness that, in the opinion of the PI, might confound the results of the study or poses an additional risk to the subject by their participation in the study.
- History or presence of alcoholism or drug abuse within the past 2 years prior to screening.
- History or presence of hypersensitivity or idiosyncratic reaction to the study drugs or inactive ingredient(s).
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 |
|---|---|---|
| TelaglenastatAlso: CB-839Glutaminase inhibitor | Drug | Telaglenastat and Famotidine, Telaglenastat and Placebo for Famotidine |
| FamotidineAlso: PepcidHistamine-H2 Receptor Antagonist | Drug | Telaglenastat and Famotidine |
| Placebo for famotidinePlacebo for Histamine-H2 Receptor Antagonist | Drug | Telaglenastat and Placebo for Famotidine |
Primary outcome
Peak Plasma Concentration (Cmax)
Time frame: Blood samples taken on Day 3 and Day 9 at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 18, 24 hours post administration of the telaglenastat
To assess the effect of famotidine on the Cmax of telaglenastat in healthy adult subjects
Time to peak plasma concentration (Tmax)
Time frame: Blood samples taken on Day 3 and Day 9 at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 18, 24 hours post administration of the telaglenastat
To assess the effect of famotidine on the Tmax of telaglenastat in healthy adult subjects
Area under the concentration-time curve from time = 0 to the last determination (AUClast)
Time frame: Blood samples taken on Day 3 and Day 9 at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 18, 24 hours post administration of the telaglenastat with and without famotidine.
To assess the effect of famotidine on the time to maximum plasma concentration (Tmax) of telaglenastat in healthy adult subjects.
Area under the concentration-time curve from time = 0 to infinity (AUC0-inf)
Time frame: Blood samples taken on Day 3 and Day 9 at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 18, 24 hours post administration of the telaglenastat with and without famotidine.
To assess the effect of famotidine on the AUC0-inf of telaglenastat in healthy adult subjects
Half-life
Time frame: Blood samples taken on Day 3 and Day 9 at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 18, 24 hours post administration of the telaglenastat with and without famotidine.
To assess the effect of famotidine on the half-life of telaglenastat in healthy adult subjects
Elimination rate
Time frame: Blood samples taken on Day 3 and Day 9 at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 18, 24 hours post administration of the telaglenastat with and without famotidine.
To assess the effect of famotidine on the elimination rate of telaglenastat in healthy adult subjects
32 secondary outcomes
Incidence of Treatment-Emergent Adverse Events
Time frame: Safety will be assessed throughout the study, starting from Day 3, prior to receiving the first dose of telaglenastat through to Day 11 when the subjects are released from the clinical site.
Incidence of changes in body temperature
Time frame: Body temperature will be assessed prior to dosing with telaglenastat on Days 2 and 9 and 24 hours after dosing on Days 4 and 11.
Incidence of changes in respiratory rate.
Time frame: Respiratory rate will be assessed prior to dosing with telaglenastat on Days 2 and 9 and 24 hours after dosing on Days 4 and 11.
Incidence of changes in blood pressure
Time frame: Blood pressure will be assessed prior to dosing with telaglenastat on Days 2 and 9 and 24 hours after dosing on Days 4 and 11.
Incidence of changes in heart rate.
Time frame: Heart rate will be assessed prior to dosing with telaglenastat on Days 2 and 9 and 24 hours after dosing on Days 4 and 11.
Electrocardiograms (ECGs)
Time frame: ECGs will be performed prior to and 4 hours after telaglenastat dosing on Days 3 and 10 and 24 hours after telaglenastat dosing on Days 4 and 11.
Hemoglobin assessments
Time frame: Assessments will be performed prior to dosing with telaglenastat on Days 2 and 9 and 24 hours after dosing on Days 4 and 11.
Hematocrit assessments
Time frame: Assessments will be performed prior to dosing with telaglenastat on Days 2 and 9 and 24 hours after dosing on Days 4 and 11.
Leukocyte count assessments
Time frame: Assessments will be performed prior to dosing with telaglenastat on Days 2 and 9 and 24 hours after dosing on Days 4 and 11.
Red blood cell count assessments
Time frame: Assessments will be performed prior to dosing with telaglenastat on Days 2 and 9 and 24 hours after dosing on Days 4 and 11.
Platelet count assessments
Time frame: Assessments will be performed prior to dosing with telaglenastat on Days 2 and 9 and 24 hours after dosing on Days 4 and 11.
Serum urea
Time frame: Assessments will be performed prior to dosing with telaglenastat on Days 2 and 9 and 24 hours after dosing on Days 4 and 11.
Serum bilirubin
Time frame: Assessments will be performed prior to dosing with telaglenastat on Days 2 and 9 and 24 hours after dosing on Days 4 and 11.
Serum alkaline phosphatase
Time frame: Assessments will be performed prior to dosing with telaglenastat on Days 2 and 9 and 24 hours after dosing on Days 4 and 11.
Serum Aspartate aminotransferase assessments
Time frame: Assessments will be performed prior to dosing with telaglenastat on Days 2 and 9 and 24 hours after dosing on Days 4 and 11.
Serum aspartate aminotransferase
Time frame: Assessments will be performed prior to dosing with telaglenastat on Days 2 and 9 and 24 hours after dosing on Days 4 and 11.
Serum albumin
Time frame: Assessments will be performed prior to dosing with telaglenastat on Days 2 and 9 and 24 hours after dosing on Days 4 and 11.
Serum sodium
Time frame: Assessments will be performed prior to dosing with telaglenastat on Days 2 and 9 and 24 hours after dosing on Days 4 and 11.
Serum potassium
Time frame: Assessments will be performed prior to dosing with telaglenastat on Days 2 and 9 and 24 hours after dosing on Days 4 and 11.
Serum chloride
Time frame: Assessments will be performed prior to dosing with telaglenastat on Days 2 and 9 and 24 hours after dosing on Days 4 and 11.
Serum glucose
Time frame: Assessments will be performed prior to dosing with telaglenastat on Days 2 and 9 and 24 hours after dosing on Days 4 and 11.
Serum creatinine
Time frame: Assessments will be performed prior to dosing with telaglenastat on Days 2 and 9 and 24 hours after dosing on Days 4 and 11.
Urine pH
Time frame: Assessments will be performed prior to dosing with telaglenastat on Days 2 and 9 and 24 hours after dosing on Days 4 and 11.
Urine Specific gravity
Time frame: Assessments will be performed prior to dosing with telaglenastat on Days 2 and 9 and 24 hours after dosing on Days 4 and 11.
Urine Protein
Time frame: Assessments will be performed prior to dosing with telaglenastat on Days 2 and 9 and 24 hours after dosing on Days 4 and 11.
Urine Glucose
Time frame: Assessments will be performed prior to dosing with telaglenastat on Days 2 and 9 and 24 hours after dosing on Days 4 and 11.
Urine Ketones
Time frame: Assessments will be performed prior to dosing with telaglenastat on Days 2 and 9 and 24 hours after dosing on Days 4 and 11.
Urine Bilirubin
Time frame: Assessments will be performed prior to dosing with telaglenastat on Days 2 and 9 and 24 hours after dosing on Days 4 and 11.
Urine Blood
Time frame: Assessments will be performed prior to dosing with telaglenastat on Days 2 and 9 and 24 hours after dosing on Days 4 and 11.
Urine Nitrite
Time frame: Assessments will be performed prior to dosing with telaglenastat on Days 2 and 9 and 24 hours after dosing on Days 4 and 11.
Urine Urobilinogen
Time frame: Assessments will be performed prior to dosing with telaglenastat on Days 2 and 9 and 24 hours after dosing on Days 4 and 11.
Urine Leukocyte esterase.
Time frame: Assessments will be performed prior to dosing with telaglenastat on Days 2 and 9 and 24 hours after dosing on Days 4 and 11.
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 9 Mar 2021.
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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 Griffin, Dr. principal investigator
Nucleus Network
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 Telaglenastat and Famotidine in people with Drug Interaction, run by Calithera Biosciences, Inc at 1 site in Australia.
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 21 inclusion and 31 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 9 Mar 2021. 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 Australia. 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. Some participants in this study may receive a placebo. 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?
Peak Plasma Concentration (Cmax) (time frame: Blood samples taken on Day 3 and Day 9 at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 18, 24 hours post administration of the telaglenastat). The study lists 6 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 9 Mar 2021.