Safety and Tolerability of CDX-6114 in Healthy Volunteers

NCT03577886 | Completed Phase 1 DMC

• 1 other identifier: CDX6114-001
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• 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

  Up to 22 days after drug administration

Secondary Outcomes (2)

• Pharmacokinetics of CDX-6114,

  Up to 24 hours after drug administration

• Pharmacodynamics of CDX-6114

  Up to 24 hours after drug administration

Study Arms (2)

CDX-6114

EXPERIMENTAL

0.225, 0.75, 2.25 and 7.5 g

Drug: CDX-6114

Placebo

PLACEBO COMPARATOR

Phosphate Buffer Diluent solution

Drug: Placebo

Interventions

CDX-6114 DRUG

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.

CDX-6114

Placebo DRUG

Phosphate Buffer Diluent oral solution

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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
• 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:

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• Codexis Inc.: lead

Study Sites (1)

Linear Clinical Services

Perth, Western Australia, 6009, Australia

Location

Study Officials

• Sam Salman

  Linear Clinical Services

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Dose-escalating, Randomized, Double-blinded, Placebo-controlled.

Study Record Dates

• First Submitted: June 14, 2018
• First Posted: July 5, 2018
• Study Start: July 4, 2018
• Primary Completion: August 21, 2018
• Study Completion: September 4, 2018
• Last Updated: September 20, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)