Healthy VolunteersPhase 1NCT04467684
Study Investigating the Safety, Tolerability, and PK, PD, of CB-0406
A Phase 1 study testing CB-0406 100 mg, CB-0406 200 mg and CB-0406 400 mg in people with Healthy Volunteers, run by Gilead Sciences at 1 site in Australia.
Trial summary
The study is designed as a single center, randomized, double-blind, placebo-controlled study to assess the PK, safety, tolerability and PD of CB-0406 in healthy participants. The study will be conducted as a 2-part study. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- CB-0406 100 mg, CB-0406 200 mg and CB-0406 400 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteAustralia
- Study dates
- 7 Jul 2020to 6 Jun 2021
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- To be eligible for study entry participants must satisfy all of the following criteria:
- Provide written informed consent before any study specific evaluation is performed;
- Healthy adult male and female volunteers between the ages of 18 and 65 years, inclusive, at screening;
- A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies:
- Not of childbearing potential, defined as surgically sterile (documented hysterectomy, bilateral salpingectomy, tubal ligation or bilateral oophorectomy - verbal confirmation through medical history review acceptable) or postmenopausal (no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy; however, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient);
- Of childbearing potential and agrees to use a highly effective method of contraception consistently during the treatment period and for at least 30 days after the dose of study treatment;
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- A male patient with a female partner of childbearing potential is eligible to participate if he and his female partner agrees to use acceptable contraception during the treatment period and for at least 30 days after the last dose of study treatment and refrains from donating sperm during this period.
- Body mass index of 18.0 to 32.0 kg/m2, inclusive, at screening;
- Hematology, clinical chemistry, coagulation and urinalysis test results within normal ranges or has no clinically relevant deviations, as determined by the investigator in consultation with sponsor, at screening and Day -1. Tests with out of range values at screening or Day -1 may be repeated once per assessment point;
- No clinically significant abnormalities noted in medical history; or discovered by physical examination, ECG assessment, or measurement of vital signs at screening and Day -1;
- Able and willing to abstain from alcohol, caffeine or caffeine-containing products, grapefruit or grapefruit juice, St John's wort, and herbal supplements for from 24 hours before Day -1 until the end of the confinement period and for 24 hours prior to additional visits to the study site.
- Agree to not engage in heavy exercise (e.g., marathon runners, weight-lifting) within 1 week prior to dosing until the final study visit.
- Able and willing to comply with the protocol and study procedures;
Who cannot join
- Participants will be excluded from the study if one or more of the following criterion are applicable:
- Has an active or recurring clinically significant disorder of the skin, head, ears, eyes, nose, or throat; an active or recurring clinically significant disorder of the respiratory, cardiovascular, gastrointestinal, endocrine/metabolic, genitourinary, neurologic, hematologic, musculoskeletal, immunologic, or psychological/psychiatric system; or a disease requiring medical treatment;
- Previous history of any surgical or medical condition that might significantly alter the absorption, distribution, metabolism, or excretion of CB-0406, such as stomach or intestinal surgery or resection (e.g., gastrectomy or any type of gastric by-pass surgery or gastric banding procedure);
- Planning any elective medical treatment or surgery during the trial period or within 30 days of Day -1;
- Any evidence or treatment of malignancy (other than localized basal cell cancer, squamous cell skin cancer, or cancer in situ that has been resected) within the previous 5 years;
- Known history of allergic reactions to or have previously received arhalofenate, MBX-102, JNJ39659100, Metaglidasen, and/or K 118;
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- Previous history or evidence at screening of sick sinus syndrome or second- or third-degree atrioventricular block or any cardiac arrhythmia other than a benign sinus arrhythmia. Participant has not had a myocardial infarction within the last 6 months;
- Clinically significant renal disease, nephrectomy, renal transplant or estimated glomerular filtration rate of <90 mL/min/1.73 m2 at screening based on Chronic Kidney Disease Epidemiology Collaboration creatinine equation (2009).
- Blood pressure after resting for at least 5 minutes that is higher than 150 mm Hg systolic or 95 mm Hg diastolic, or lower than 90 mm Hg systolic or 50 mm Hg diastolic at screening or Day -1. A single repeat measurement at screening or Day -1 is allowed based on the investigator's judgment;
- Pulse rate obtained from vital signs after resting for 5 minutes that is outside the range of 45 to 90 beats per minute at screening or Day -1. A single repeat measurement is allowed at screening and Day -1 for eligibility based on the investigator's judgment;
- History of drug or alcohol abuse within the last 2 years;
- Positive screen for drugs of abuse (amphetamines, methamphetamines, methadone, barbiturates, benzodiazepines, cocaine, opiates, methylenedioxymethamphetamine, phencyclidine, tetrahydrocannabinol), tricyclic antidepressants, cotinine or alcohol at screening or Day -1;
- Smoke more than 2 cigarettes per week and have a positive cotinine test at screening or Day -1. Participants must agree to refrain from smoking from 24 hours prior to Day -1 until completion of the end of study (EOS) visit.
- Used or are using prescription or over-the-counter medications, dietary/nutritional supplements (except for multivitamins at the recommended dose and paracetamol, up to 2g in any one day) within 14 days prior to Day 1 and for the duration of the trial.
- Received an investigational drug within 30 days or 5 half -lives (whichever is longer) prior to Day 1.
- Donated more than 450 mL of blood within 30 days prior to Day 1;
- Evidence of clinically significant hepatic impairment including alanine aminotransferase or aspartate aminotransferase >1.5 times the upper limit of normal, with the exception of elevated bilirubin due to Gilbert's syndrome based on bilirubin fractionation at screening;
- Positive test result at screening for human immunodeficiency virus (Types 1 or 2) antibody, hepatitis B surface antigen, or hepatitis C virus antibody;
- Clinically significant acute illness within 4 weeks or other illness deemed to be significant by investigator with agreement of sponsor within 5 days before Day 1;
- Participant or a family member of the participant is a member of the professional or ancillary personnel working at the investigative site involved in the study;
- Participant, in the opinion of the investigator, should not participate in the study;
- Participant has received blood products within 2 months prior to Day -1.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Double-Blind, Placebo Controlled, Dose-Escalation Study Investigating the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of CB-0406 Tablets in Healthy Volunteers
The study is designed as a single center, randomized, double-blind, placebo-controlled study to assess the PK, safety, tolerability and PD of CB-0406 in healthy participants. The study will be conducted as a 2-part study.
Read the detailed description
The study is designed as a 2-part study:
Part 1 is designed as single ascending dose (SAD) escalation study investigating 5 dose levels. Each cohort will consist of participants (N=8) to be randomly assigned to receive a blinded oral dose of CB-0406 (n=6) or placebo (n=2). Dose levels of CB-0406 in the sequential cohorts will be 100 mg, 200 mg, 400 mg, 800 mg or 1000 mg to be administered once on each cohorts study Day 1.
Part 2 is designed as multiple ascending dose (MAD) escalation study investigating up to 5 dose levels as determined by the SAD cohort. Doses will be determined following completion and review of the safety and PK findings for Cohorts 1 to Cohort 5 in Part 1.
- Conditions
- Healthy Volunteers
- Being tested
- CB-0406 100 mg, CB-0406 200 mg, CB-0406 400 mg, CB-0406 800 mg, CB-0406 1,000 mg
- Keywords
- single ascending dose (SAD), multiple ascending dose (MAD), CymaBay, CB-0406, arhalofenate, peroxisome proliferator-activated receptor gamma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CB-0406 100 mgDrug
Single oral dose
CB-0406 200 mgDrug
Single oral dose
CB-0406 400 mgDrug
Single oral dose
CB-0406 800 mgDrug
Single oral dose
CB-0406 1,000 mgDrug
Single oral dose
Matched placeboDrug
Color and size matched placebo
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Cohort 1: 100 mg CB-0406 (n=6) Receives: Drug: CB-0406 100 mg |
| Cohort 2 | Experimental | Cohort 2: 200 mg CB-0406 (n=6). Dose initiated following review of all safety data from Cohort 1 by a Safety Review Committee Receives: Drug: CB-0406 200 mg |
| Cohort 3 | Experimental | Cohort 3: 400 mg CB-0406 (n=6). Dose initiated following review of all safety data and PK data from Cohort 2 by a Safety Review Committee. Receives: Drug: CB-0406 400 mg |
| 800 mg | Experimental | Cohort 4: 800 mg CB-0406 (n=6). Dose initiated following review of all safety data and PK data from Cohort 3 by a Safety Review Committee. Receives: Drug: CB-0406 800 mg |
| 1000 mg | Experimental | Cohort 5: 1000 mg CB-0406 (n=6). Dose initiated following review of all safety data and PK data from Cohort 4 by a Safety Review Committee Receives: Drug: CB-0406 1,000 mg |
| Matched placebo | Placebo comparator | Two subjects in each Cohort (1, 2, 3, 4, 5) are randomized to matched placebo Receives: Drug: Matched placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic Parameters
Concentration of CB-0406 in plasma.
Measured: Part 1: Day 1 to Day 15; Part 2: Day 14 to Day 28
Secondary outcomes (6)
Incidence of Treatment-Emergent Adverse Events
Incidence of adverse events
Measured: Part 1: Day 1 to Day 22; Part 2: Day 1 to Day 35
Pharmacodynamic Activity
Evaluation of relative changes from baseline in plasma IL-1β and serum urate over time
Measured: Part 1: Day 1 to Day 15; Part 2: Day 14 to Day 28
Incidence of abnormal laboratory tests results
Evaluation of clinically significant changes from baseline in laboratory evaluation (hematology, chemistry, coagulation, urinalysis)
Measured: Part 1: Screening, Day -1, Day 2, Day 4, Day 9, Day 15, EOS/ET Part 2: Screening, Day -1, Day 2 to 13, Day 14, Day 16, Day 20, Day 28, EOS/ET
Incidence of Abnormal Vital Signs
Evaluation of clinically significant changes in vital signs will include body temperature (tympanic), respiratory rate, heart rate and systolic and diastolic blood pressure
Measured: Part 1: Every visit; Part 2 Every visit
Incidence of Abnormal ECGs
The following parameters will be assessed using a 12-lead ECG: heart rate, PR, QRS, QT, QTcF (Fridericia's formula).
Measured: Part 1: Screening, Day 1, Day 2, Day 3, Day 4, Day 9, Day 15, EOS/ET; Part 2 Screening, Day 1, Day 2 to 13, Day 14, Day 16, Day 20, Day 28, Day 35
Incidence of Abnormal Physical Exams
Assessments of the skin, lungs, cardiovascular system, and abdomen (liver and spleen)
Measured: Part 1: Day -1 and at the EOS/ET visit; Part 2 Screening, Day 1, Day 2 to 13, Day 4, Day 16, Day 20, Day 28, EOS/ET
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2020
- Study start7 Jul 2020
- Primary completion30 May 2021
- Study completion6 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies 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
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Elaine Watkins, DO, MSPH, Study director, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04467684
- Sponsor's protocol ID
- CB0406-12047
- Status last verified
- Jun 2021
- First submitted
- 29 Jun 2020
- Last updated
- 11 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Aronow WS, Harding PR, Khursheed M, Vangrow JS, Papageorge's NP, Mays J. Effect of halofenate on serum lipids. Clin Pharmacol Ther. 1973 May-Jun;14(3):358-65. doi: 10.1002/cpt1973143358. No abstract available.
PubMed 4572798Dujovne CA, Azarnoff DL, Pentikainen P, Manion C, Hurwitz A, Hassanein K. A two-year crossover therapeutic trial with halofenate and clofibrate. Am J Med Sci. 1976 Nov-Dec;272(3):277-84. doi: 10.1097/00000441-197611000-00005.
PubMed 797258
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-Blind, Placebo Controlled, Dose-Escalation Study Investigating the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of CB-0406 Tablets in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT04467684
- Acronym / sponsor ID
- CB0406-12047
- Conditions
- Healthy Volunteers
- Keywords
- single ascending dose (SAD), multiple ascending dose (MAD), CymaBay, CB-0406, arhalofenate, peroxisome proliferator-activated receptor gamma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- 7 Jul 2020 (actual)
- Primary completion
- 30 May 2021 (actual)
- Study completion
- 6 Jun 2021 (actual)
- First posted
- 13 Jul 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.
The study is designed as a single center, randomized, double-blind, placebo-controlled study to assess the PK, safety, tolerability and PD of CB-0406 in healthy participants. The study will be conducted as a 2-part study.
Detailed description
The study is designed as a 2-part study:
Part 1 is designed as single ascending dose (SAD) escalation study investigating 5 dose levels. Each cohort will consist of participants (N=8) to be randomly assigned to receive a blinded oral dose of CB-0406 (n=6) or placebo (n=2). Dose levels of CB-0406 in the sequential cohorts will be 100 mg, 200 mg, 400 mg, 800 mg or 1000 mg to be administered once on each cohorts study Day 1.
Part 2 is designed as multiple ascending dose (MAD) escalation study investigating up to 5 dose levels as determined by the SAD cohort. Doses will be determined following completion and review of the safety and PK findings for Cohorts 1 to Cohort 5 in Part 1.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: CB-0406 100 mgCohort 1: 100 mg CB-0406 (n=6) |
| Cohort 2 | Experimental | Drug: CB-0406 200 mgCohort 2: 200 mg CB-0406 (n=6). Dose initiated following review of all safety data from Cohort 1 by a Safety Review Committee |
| Cohort 3 | Experimental | Drug: CB-0406 400 mgCohort 3: 400 mg CB-0406 (n=6). Dose initiated following review of all safety data and PK data from Cohort 2 by a Safety Review Committee. |
| 800 mg | Experimental | Drug: CB-0406 800 mgCohort 4: 800 mg CB-0406 (n=6). Dose initiated following review of all safety data and PK data from Cohort 3 by a Safety Review Committee. |
| 1000 mg | Experimental | Drug: CB-0406 1,000 mgCohort 5: 1000 mg CB-0406 (n=6). Dose initiated following review of all safety data and PK data from Cohort 4 by a Safety Review Committee |
| Matched placebo | Placebo comparator | Drug: Matched placeboTwo subjects in each Cohort (1, 2, 3, 4, 5) are randomized to matched placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Provide written informed consent before any study specific evaluation is performed;
- Healthy adult male and female volunteers between the ages of 18 and 65 years, inclusive, at screening;
- A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies:
- A male patient with a female partner of childbearing potential is eligible to participate if he and his female partner agrees to use acceptable contraception during the treatment period and for at least 30 days after the last dose of study treatment and refrains from donating sperm during this period.
- Body mass index of 18.0 to 32.0 kg/m2, inclusive, at screening;
Key exclusion criteria (22 listed)
- Participants will be excluded from the study if one or more of the following criterion are applicable:
- Has an active or recurring clinically significant disorder of the skin, head, ears, eyes, nose, or throat; an active or recurring clinically significant disorder of the respiratory, cardiovascular, gastrointestinal, endocrine/metabolic, genitourinary, neurologic, hematologic, musculoskeletal, immunologic, or psychological/psychiatric system; or a disease requiring medical treatment;
- Previous history of any surgical or medical condition that might significantly alter the absorption, distribution, metabolism, or excretion of CB-0406, such as stomach or intestinal surgery or resection (e.g., gastrectomy or any type of gastric by-pass surgery or gastric banding procedure);
- Planning any elective medical treatment or surgery during the trial period or within 30 days of Day -1;
- Any evidence or treatment of malignancy (other than localized basal cell cancer, squamous cell skin cancer, or cancer in situ that has been resected) within the previous 5 years;
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 |
|---|---|---|
| CB-0406 100 mgSingle oral dose | Drug | Cohort 1 |
| CB-0406 200 mgSingle oral dose | Drug | Cohort 2 |
| CB-0406 400 mgSingle oral dose | Drug | Cohort 3 |
| CB-0406 800 mgSingle oral dose | Drug | 800 mg |
| CB-0406 1,000 mgSingle oral dose | Drug | 1000 mg |
| Matched placeboColor and size matched placebo | Drug | Matched placebo |
Primary outcome
Pharmacokinetic Parameters
Time frame: Part 1: Day 1 to Day 15; Part 2: Day 14 to Day 28
Concentration of CB-0406 in plasma.
6 secondary outcomes
Incidence of Treatment-Emergent Adverse Events
Time frame: Part 1: Day 1 to Day 22; Part 2: Day 1 to Day 35
Pharmacodynamic Activity
Time frame: Part 1: Day 1 to Day 15; Part 2: Day 14 to Day 28
Incidence of abnormal laboratory tests results
Time frame: Part 1: Screening, Day -1, Day 2, Day 4, Day 9, Day 15, EOS/ET Part 2: Screening, Day -1, Day 2 to 13, Day 14, Day 16, Day 20, Day 28, EOS/ET
Incidence of Abnormal Vital Signs
Time frame: Part 1: Every visit; Part 2 Every visit
Incidence of Abnormal ECGs
Time frame: Part 1: Screening, Day 1, Day 2, Day 3, Day 4, Day 9, Day 15, EOS/ET; Part 2 Screening, Day 1, Day 2 to 13, Day 14, Day 16, Day 20, Day 28, Day 35
Incidence of Abnormal Physical Exams
Time frame: Part 1: Day -1 and at the EOS/ET visit; Part 2 Screening, Day 1, Day 2 to 13, Day 4, Day 16, Day 20, Day 28, EOS/ET
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 11 Jun 2021.
- Background: PubMed 4572798Aronow WS, Harding PR, Khursheed M, Vangrow JS, Papageorge's NP, Mays J. Effect of halofenate on serum lipids. Clin Pharmacol Ther. 1973 May-Jun;14(3):358-65. doi: 10.1002/cpt1973143358. No abstract available.
- Background: PubMed 797258Dujovne CA, Azarnoff DL, Pentikainen P, Manion C, Hurwitz A, Hassanein K. A two-year crossover therapeutic trial with halofenate and clofibrate. Am J Med Sci. 1976 Nov-Dec;272(3):277-84. doi: 10.1097/00000441-197611000-00005.
- CymaBay TherapeuticsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Elaine Watkins, DO, MSPH 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 CB-0406 100 mg, CB-0406 200 mg and CB-0406 400 mg in people with Healthy Volunteers, run by Gilead Sciences 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 13 inclusion and 22 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 11 Jun 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?
Pharmacokinetic Parameters (time frame: Part 1: Day 1 to Day 15; Part 2: Day 14 to Day 28). 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 NCT04467684, which also lists 2 linked publications.
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 11 Jun 2021.