HealthyPhase 1NCT03577886
Safety and Tolerability of CDX-6114 in Healthy Volunteers
A Phase 1 study testing CDX-6114 in people with Healthy, run by Codexis Inc. at 1 site in Australia.
Trial summary
The purpose of this study is to assess the safety and tolerability of an oral solution of CDX-6114 when administered as a single dose in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- CDX-6114
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteAustralia
- Study dates
- 4 Jul 2018to 4 Sep 2018
- 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 male and female, non-smoking, subjects between the ages of 18 and 55 years, inclusive, at the time of screening.
- Have a body mass index (BMI) between 18.0 and 30.0 kg/m2 inclusive and weigh at least 50 kg and no more than 100 kg inclusive.
- Good general health, as determined by an experienced physician based on a medical evaluation including detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead electrocardiogram (ECG), neurological assessment and clinical laboratory tests.
- Male subjects and their female spouse/partner(s) who are of childbearing potential:
- Must agree to stay abstinent (where abstinence is the preferred and usual life-style of the subject), starting at screening and continuing throughout the clinical study period, and for 90 days after study drug administration.
- Or
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- Must be using highly effective contraception consisting of 2 forms of birth control (1 of which must be a barrier method) starting at screening and continuing throughout the clinical study period, and for 90 days after study drug administration.
- These requirements do not apply to participants in a same sex relationship.
- Male subjects must agree not to donate sperm starting at screening and continuing throughout the clinical study period, and for 90 days after study drug administration.
- Female subjects of childbearing potential:
- Must agree not to become pregnant during the clinical study period and for 30 days after study drug administration.
- Must have a negative serum pregnancy test at screening.
- If heterosexually active, must agree to consistently use a form of highly effective birth control, in combination with a barrier method starting at screening and continuing throughout the clinical study period, and for 30 days after study drug administration
- Or
- Must agree to stay abstinent (where abstinence is the preferred and usual life-style of the subject), starting at screening and continuing throughout the clinical study period, and for 30 days after study drug administration.
- These requirements do not apply to participants in a same sex relationship.
- Female subjects of non-childbearing potential:
- Must have a confirmed clinical history of sterility
- Or
- Must be postmenopausal as defined as: amenorrhea for at least 1 year prior to screening and a laboratory confirmed serum follicle stimulating hormone (FSH) level ≥ 40mIU/mL.
- Female subjects must agree not to breastfeed starting at screening and continuing throughout the clinical study period, and for 90 days after study drug administration.
- Female subjects must agree not to donate ova starting at screening and continuing throughout the clinical study period, and for 90 days after study drug administration.
- Subject must be competent to understand the nature of the study \& capable of giving written informed consent. Be willing to report for the scheduled study visits and communicate to study personnel about adverse events and concomitant medication use.
- Subject must abstain from the following foods from 1 week prior to study drug administration until the last PK sample has been obtained: grapefruit juice or products, pomegranate juice or products, foods containing poppy seeds, and/or drinks or foods containing quinine (e.g., tonic water) or Seville oranges (e.g. orange marmalade).
- Subject agrees not to participate in another interventional study while participating in the present clinical study.
Who cannot join
- Female subject who has been pregnant within the 6 months prior to screening or breastfeeding within the 3 months prior to screening.
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies and childhood asthma) at time of screening or study drug administration.
- Current or chronic history of gastrointestinal disorders or conditions interfering with normal gastrointestinal anatomy or motility. Examples include gastrointestinal bypass surgery, cholecystectomy, partial or total gastrectomy, gastric band surgery, small bowel resection, vagotomy, malabsorption, Crohn's disease, ulcerative colitis, irritable bowel syndrome (IBS) or celiac sprue.
- Treatment with any anti-platelet and/or anticoagulant medication.
- Evidence or history of specific food intolerance. Examples include gluten intolerance, lactose intolerance, or dairy food intolerance or any food/ingredient included in the standard protein breakfast.
- A positive result, on screening, for serum hepatitis B surface antigen (HBsAg), hepatitis A virus antibodies (HAV), hepatitis C virus antibodies (HCV) or antibodies to human immunodeficiency virus type 1 (HIV-1) and/or type 2 (HIV-2).
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- A positive pre-study drug/alcohol screen. However, there is the option to re-screen during the screening period at the discretion of the Principal Investigator (PI) or delegate in the case of a positive pre-study drug screen for a prescribed medication e.g. codeine.
- Subject has a history of drinking > 21 units of alcohol/week for male subjects or > 14 units of alcohol/week for female subjects within the 3 months prior to screening.
- Subject has a history of regular smoking (daily or most days in a week) or the use of nicotine products (3 or more nicotine-containing products) within the 6 months prior to screening.
- Subject has used any recreational drugs of abuse within the 3 months prior to screening.
- Subject has a pulse rate <40 or > 100 bpm; mean systolic blood pressure (SBP) > 140 mmHg; mean diastolic blood pressure (DBP) > 90 mmHg at screening. Repeat measurements are allowed at the discretion of the PI or delegate.
- Subject has any clinically significant abnormalities at screening in rhythm, conduction or morphology of the resting ECG and any clinically significant abnormalities in the 12-lead ECG, as considered by the Investigator, that may interfere with the interpretation of QTc interval changes including abnormal ST-T wave morphology.
- Subject has prolonged QTcF (QT interval corrected for heart rate using Fridericia's formula) > 450 ms for male subjects or > 470 ms for female subjects, or a shortened QTcF < 300 ms or a family history of prolonged QT syndrome, at screening.
- Subject has any clinically significant abnormalities in clinical chemistry, hematology, or urinalysis at screening as judged by the Investigator, including: Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), alkaline phosphatase (ALP), gamma glutamyl transferase (GGT) or Total bilirubin (TBL) up to 1.5 times above the Upper Limit of Normal (ULN).
- Plasma donation within the 14 days prior to screening or any whole blood donation/significant blood loss > 500 mL during the 3 months prior to screening.
- Treatment with any Investigational Drug or Device/Treatment within the 30 days prior to the administration of study drug.
- Use of any prescribed or non-prescribed medication including herbal and dietary supplements, antacids, analgesics (other than oral contraceptives, paracetamol or multi-vitamins) during the two weeks prior to the administration of the study drug, or up to a minimum of 5 times the half-life of the medication if it has a long half-life.
- Exposure to more than four new chemical entities within the 12-month period prior to the administration of the study medication.
- Known allergy or adverse reaction history to any of the oral dose formulation components e.g. mannitol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CDX-6114 Following Single, Ascending Oral Dose Administration to Healthy Volunteers.
The purpose of this study is to assess the safety and tolerability of an oral solution of CDX-6114 when administered as a single dose in healthy volunteers.
Read the detailed description
This is a Phase 1, double-blind, placebo-controlled study in approximately 32 healthy volunteers who are 18 to 55 years old. Four cohorts are planned, each consisting of 8 subjects; the cohorts as planned are 0.225, 0.75, 2.25, and 7.5 g in oral solution. Increasing doses of CDX-6114 will be assessed sequentially until the final dose is evaluated or any of the stopping criteria are reached. Subjects will each receive a single dose and then will be followed for a total of 22 days (3 weeks).
- Conditions
- Healthy
- Being tested
- CDX-6114, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CDX-6114Drug
CDX-6114 will be administered as a single, oral dose solution at dose levels of 0.225, 0.75, 2.25, and 7.5 g.
PlaceboDrug
Phosphate Buffer Diluent oral solution
| Study group | Role | What they receive |
|---|---|---|
| CDX-6114 | Experimental | 0.225, 0.75, 2.25 and 7.5 g Receives: Drug: CDX-6114 |
| Placebo | Placebo comparator | Phosphate Buffer Diluent solution Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome measure of the study will be the incidence of treatment-emergent Adverse events experienced by the Subjects following oral administration of CDX-6114
Will be measured by assessing the frequency and the nature of the AE's reported
Measured: Up to 22 days after drug administration
Secondary outcomes (2)
Pharmacokinetics of CDX-6114,
Assessed by the serum levels of CDX-6114 following oral administration of CDX-6114
Measured: Up to 24 hours after drug administration
Pharmacodynamics of CDX-6114
Assessed by the plasma levels of Phenylalanine and Cinnamic acid following oral administration of CDX-6114.
Measured: Up to 24 hours after drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2018
- Study start4 Jul 2018
- Primary completion21 Aug 2018
- Study completion4 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Dose-escalating, Randomized, Double-blinded, Placebo-controlled.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Codexis Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sam Salman, Principal investigator, Linear Clinical Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03577886
- Sponsor's protocol ID
- CDX6114-001
- Status last verified
- Jul 2018
- First submitted
- 14 Jun 2018
- Last updated
- 20 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CDX-6114 Following Single, Ascending Oral Dose Administration to Healthy Volunteers.
- ClinicalTrials.gov ID
- NCT03577886
- Acronym / sponsor ID
- CDX6114-001
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Codexis Inc.Industry (pharma, biotech, devices)
- Study start
- 4 Jul 2018 (actual)
- Primary completion
- 21 Aug 2018 (actual)
- Study completion
- 4 Sep 2018 (actual)
- First posted
- 5 Jul 2018 (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 purpose of this study is to assess the safety and tolerability of an oral solution of CDX-6114 when administered as a single dose in healthy volunteers.
Detailed description
This is a Phase 1, double-blind, placebo-controlled study in approximately 32 healthy volunteers who are 18 to 55 years old. Four cohorts are planned, each consisting of 8 subjects; the cohorts as planned are 0.225, 0.75, 2.25, and 7.5 g in oral solution. Increasing doses of CDX-6114 will be assessed sequentially until the final dose is evaluated or any of the stopping criteria are reached. Subjects will each receive a single dose and then will be followed for a total of 22 days (3 weeks).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Dose-escalating, Randomized, Double-blinded, Placebo-controlled.
| Arm | Type | Receives |
|---|---|---|
| CDX-6114 | Experimental | Drug: CDX-61140.225, 0.75, 2.25 and 7.5 g |
| Placebo | Placebo comparator | Drug: PlaceboPhosphate Buffer Diluent solution |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (25 listed)
- Healthy male and female, non-smoking, subjects between the ages of 18 and 55 years, inclusive, at the time of screening.
- Have a body mass index (BMI) between 18.0 and 30.0 kg/m2 inclusive and weigh at least 50 kg and no more than 100 kg inclusive.
- Good general health, as determined by an experienced physician based on a medical evaluation including detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead electrocardiogram (ECG), neurological assessment and clinical laboratory tests.
- Male subjects and their female spouse/partner(s) who are of childbearing potential:
- Or
Key exclusion criteria (19 listed)
- Female subject who has been pregnant within the 6 months prior to screening or breastfeeding within the 3 months prior to screening.
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies and childhood asthma) at time of screening or study drug administration.
- Current or chronic history of gastrointestinal disorders or conditions interfering with normal gastrointestinal anatomy or motility. Examples include gastrointestinal bypass surgery, cholecystectomy, partial or total gastrectomy, gastric band surgery, small bowel resection, vagotomy, malabsorption, Crohn's disease, ulcerative colitis, irritable bowel syndrome (IBS) or celiac sprue.
- Treatment with any anti-platelet and/or anticoagulant medication.
- Evidence or history of specific food intolerance. Examples include gluten intolerance, lactose intolerance, or dairy food intolerance or any food/ingredient included in the standard protein breakfast.
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 |
|---|---|---|
| CDX-6114CDX-6114 will be administered as a single, oral dose solution at dose levels of 0.225, 0.75, 2.25, and 7.5 g. | Drug | CDX-6114 |
| PlaceboPhosphate Buffer Diluent oral solution | Drug | Placebo |
Primary outcome
The primary outcome measure of the study will be the incidence of treatment-emergent Adverse events experienced by the Subjects following oral administration of CDX-6114
Time frame: Up to 22 days after drug administration
Will be measured by assessing the frequency and the nature of the AE's reported
2 secondary outcomes
Pharmacokinetics of CDX-6114,
Time frame: Up to 24 hours after drug administration
Pharmacodynamics of CDX-6114
Time frame: Up to 24 hours after drug administration
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 20 Sep 2018.
- 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.
Sam Salman principal investigator
Linear Clinical Services
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 CDX-6114 in people with Healthy, run by Codexis 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 25 inclusion and 19 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 20 Sep 2018. 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?
The primary outcome measure of the study will be the incidence of treatment-emergent Adverse events experienced by the Subjects following oral administration of CDX-6114 (time frame: Up to 22 days after drug administration). 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 20 Sep 2018.