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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03577886




Registration number
NCT03577886
Ethics application status
Date submitted
14/06/2018
Date registered
5/07/2018

Titles & IDs
Public title
Safety and Tolerability of CDX-6114 in Healthy Volunteers
Scientific 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.
Secondary ID [1] 0 0
CDX6114-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - CDX-6114
Treatment: Drugs - Placebo

Experimental: CDX-6114 - 0.225, 0.75, 2.25 and 7.5 g

Placebo comparator: Placebo - Phosphate Buffer Diluent solution


Treatment: Drugs: CDX-6114
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.

Treatment: Drugs: Placebo
Phosphate Buffer Diluent oral solution
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
Up to 22 days after drug administration
Secondary outcome [1] 0 0
Pharmacokinetics of CDX-6114,
Timepoint [1] 0 0
Up to 24 hours after drug administration
Secondary outcome [2] 0 0
Pharmacodynamics of CDX-6114
Timepoint [2] 0 0
Up to 24 hours after drug administration

Eligibility
Key inclusion criteria
1. Healthy male and female, non-smoking, subjects between the ages of 18 and 55 years, inclusive, at the time of screening.
2. 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.
3. 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.
4. Male subjects and their female spouse/partner(s) who are of childbearing potential:

1. 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
2. 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.
3. These requirements do not apply to participants in a same sex relationship.
5. 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.
6. Female subjects of childbearing potential:

1. Must agree not to become pregnant during the clinical study period and for 30 days after study drug administration.
2. Must have a negative serum pregnancy test at screening.
3. 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
4. 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.
5. These requirements do not apply to participants in a same sex relationship.
7. Female subjects of non-childbearing potential:

1. Must have a confirmed clinical history of sterility

Or
2. 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.
8. 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.
9. 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.
10. 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.
11. 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).
12. Subject agrees not to participate in another interventional study while participating in the present clinical study.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Female subject who has been pregnant within the 6 months prior to screening or breastfeeding within the 3 months prior to screening.
2. 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.
3. 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.
4. Treatment with any anti-platelet and/or anticoagulant medication.
5. 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.
6. 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).
7. 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.
8. 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.
9. 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.
10. Subject has used any recreational drugs of abuse within the 3 months prior to screening.
11. 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.
12. 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.
13. 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.
14. 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).
15. 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.
16. Treatment with any Investigational Drug or Device/Treatment within the 30 days prior to the administration of study drug.
17. 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.
18. Exposure to more than four new chemical entities within the 12-month period prior to the administration of the study medication.
19. Known allergy or adverse reaction history to any of the oral dose formulation components e.g. mannitol.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
4/07/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
4/09/2018
Sample size
Target
Accrual to date
Final
32
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Linear Clinical Services - Perth
Recruitment postcode(s) [1] 0 0
6009 - Perth

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Codexis Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Sam Salman
Address 0 0
Linear Clinical Services
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03577886