Safety, Tolerability, and Pharmacokinetic Study of CAT-1004 in Healthy Adult Volunteers
A Single Center, Randomized, Double-Blind, Placebo-Controlled, Ascending Dose, Safety, Tolerability, and Pharmacokinetic Study of CAT-1004 in Healthy Adult Volunteers
1 other identifier
interventional
52
1 country
1
Brief Summary
- To evaluate the safety and tolerability of escalating single doses of CAT-1004 relative to placebo in healthy adult volunteers.
- To evaluate the pharmacokinetics (PK) of escalating single doses of CAT-1004 in healthy adult volunteers.
- To evaluate the effect of a high-fat meal on single doses of CAT-1004 in healthy adult volunteers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 healthy
Started Sep 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2011
CompletedFirst Submitted
Initial submission to the registry
September 8, 2011
CompletedFirst Posted
Study publicly available on registry
September 26, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2012
CompletedFebruary 6, 2012
February 1, 2012
4 months
September 8, 2011
February 2, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety
Safety Endpoints: Laboratory evaluations including hematology, chemistry, coagulation and urinalysis, physical examinations, AEs, serious AEs (SAEs), ECGs, and vital signs.
Change from Baseline versus Day-1 though 72 hrs post dose and EOT/FU
Secondary Outcomes (1)
Pharmacokinetic Profile
Plasma blood samples through 72 hrs, urine collections through 48 hrs
Study Arms (9)
Cohort 1 / Dose level 1
EXPERIMENTALSingle dose orally: CAT-1004 Dose level 1 or placebo
Cohort 2 / Dose level 2
EXPERIMENTALSingle dose orally: CAT-1004 Dose level 2 or placebo
Cohort 3 /Dose level 3
EXPERIMENTALSingle dose orally: CAT-1004 Dose level 3 or placebo
Cohort 4/ Dose level 4
EXPERIMENTALSingle dose orally: CAT-1004 Dose level 4 or placebo
Cohort 5/ Dose level 5
EXPERIMENTALSingle dose orally: CAT-1004 Dose level 5 or placebo
Cohort 2/ Dose level 2 ( FE)
EXPERIMENTALSingle dose orally (Under fed conditions): CAT-1004 Dose level 2 or placebo
Cohort 3/ Dose level 3 (FE)
EXPERIMENTALSingle dose orally (Under fed conditions): CAT-1004 Dose level 3 or placebo
Cohort 6 / Dose level 6 (FE)
EXPERIMENTALSingle dose orally (Under fed conditions) CAT-1004 Dose level 4 or placebo Subjects may be reenrolled from Cohort 4.
Cohort 7 / Dose level 7 (FE)
EXPERIMENTALSingle dose orally (Under fed conditions)CAT-1004 Dose level 5 or placebo Subjects may be reenrolled from Cohort 5.
Interventions
Single dose oral administration of CAT1004 or placebo-6 to 8 subjects will be treated with CAT-1004 per cohort.
Single dose oral administration of CAT1004 or placebo- 2 subjects treated with placebo per cohort.
Eligibility Criteria
You may qualify if:
- In good health.
- Age: 19 to 55 years inclusive at Screening.
- Satisfies one of the following
- Females not of childbearing potential: non-pregnant and non-lactating; surgically sterile or postmenopausal, OR
- Males: surgically sterile, abstinent, or subject or partner is utilizing an acceptable contraceptive method during and 3 months after the last study dose.
- BMI: 18 to 30 kg/m2 at Screening.
You may not qualify if:
- Clinically significant abnormalities in physical examination or vital signs.
- Clinically significant electrocardiogram (ECG) abnormalities as assessed by the investigator.
- Clinically significant screening laboratory result as assessed by the Investigator.
- The subject has a history of clinically significant allergies (except for untreated, asymptomatic seasonal allergies at the time of dosing), or hematological, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurological disease.
- History or presence of malignancy with the past 5 years.
- History of alcohol or substance abuse or eating disorder within 2 years, OR regular use of alcohol within 6 months (\>14 units of alcohol per week; 1 unit = 150 mL of wine, 360 mL of beer, or 45 mL of 40% alcohol).
- Use of any investigational drug or participation in any investigational study within 30 days prior to screening. For dose levels 6 and 7 fed cohorts, subjects may participate who have taken part in the dose levels 4 and 5 fasted cohort.
- Any significant blood loss within 60 days prior to screening, e.g. blood donation, participation in study with multiple blood draws, etc.
- Any condition, disease, disorder or clinically relevant laboratory abnormality that, in the opinion of the Investigator, would jeopardize the subject's appropriate participation in this study or obscure the effects of treatment.
- A suspected allergy or sensitivity to CAT-1004 or excipients based upon known allergies to excipients or compounds of a similar class.
- Any clinically significant systemic infection within 3 weeks prior to screening.
- Use of prescription medications within 30 days of screening.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Celerion Clinical Research Unit
Lincoln, Nebraska, 68502, United States
MeSH Terms
Interventions
Study Officials
- PRINCIPAL INVESTIGATOR
Scott Rasmussen, MD
Celerion
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 8, 2011
First Posted
September 26, 2011
Study Start
September 1, 2011
Primary Completion
January 1, 2012
Study Completion
January 1, 2012
Last Updated
February 6, 2012
Record last verified: 2012-02