Safety, Tolerability, and Pharmacokinetic Study of CAT-1004 in Healthy Adult Volunteers

• ClinicalTrials.gov Identifier: NCT01440166
• Recruitment Status: Completed
• First Posted: September 26, 2011
• Last Update Posted: February 6, 2012
• Sponsor: Catabasis Pharmaceuticals
• Information provided by (Responsible Party): Catabasis Pharmaceuticals

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Healthy	Drug: Drug; Other: Placebo	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 52 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Official Title: A Single Center, Randomized, Double-Blind, Placebo-Controlled, Ascending Dose, Safety, Tolerability, and Pharmacokinetic Study of CAT-1004 in Healthy Adult Volunteers
• Study Start Date: September 2011
• Actual Primary Completion Date: January 2012
• Actual Study Completion Date: January 2012

Arms and Interventions

Arm	Intervention/treatment
Experimental: Cohort 1 / Dose level 1; Single dose orally: CAT-1004 Dose level 1 or placebo	Drug: Drug; Single dose oral administration of CAT1004 or placebo-6 to 8 subjects will be treated with CAT-1004 per cohort.; Other Name: CAT-1004; Other: Placebo; Single dose oral administration of CAT1004 or placebo- 2 subjects treated with placebo per cohort.
Experimental: Cohort 2 / Dose level 2; Single dose orally: CAT-1004 Dose level 2 or placebo	Drug: Drug; Single dose oral administration of CAT1004 or placebo-6 to 8 subjects will be treated with CAT-1004 per cohort.; Other Name: CAT-1004; Other: Placebo; Single dose oral administration of CAT1004 or placebo- 2 subjects treated with placebo per cohort.
Experimental: Cohort 3 /Dose level 3; Single dose orally: CAT-1004 Dose level 3 or placebo	Drug: Drug; Single dose oral administration of CAT1004 or placebo-6 to 8 subjects will be treated with CAT-1004 per cohort.; Other Name: CAT-1004; Other: Placebo; Single dose oral administration of CAT1004 or placebo- 2 subjects treated with placebo per cohort.
Experimental: Cohort 4/ Dose level 4; Single dose orally: CAT-1004 Dose level 4 or placebo	Drug: Drug; Single dose oral administration of CAT1004 or placebo-6 to 8 subjects will be treated with CAT-1004 per cohort.; Other Name: CAT-1004; Other: Placebo; Single dose oral administration of CAT1004 or placebo- 2 subjects treated with placebo per cohort.
Experimental: Cohort 5/ Dose level 5; Single dose orally: CAT-1004 Dose level 5 or placebo	Drug: Drug; Single dose oral administration of CAT1004 or placebo-6 to 8 subjects will be treated with CAT-1004 per cohort.; Other Name: CAT-1004; Other: Placebo; Single dose oral administration of CAT1004 or placebo- 2 subjects treated with placebo per cohort.
Experimental: Cohort 2/ Dose level 2 ( FE); Single dose orally (Under fed conditions): CAT-1004 Dose level 2 or placebo	Drug: Drug; Single dose oral administration of CAT1004 or placebo-6 to 8 subjects will be treated with CAT-1004 per cohort.; Other Name: CAT-1004; Other: Placebo; Single dose oral administration of CAT1004 or placebo- 2 subjects treated with placebo per cohort.
Experimental: Cohort 3/ Dose level 3 (FE); Single dose orally (Under fed conditions): CAT-1004 Dose level 3 or placebo	Drug: Drug; Single dose oral administration of CAT1004 or placebo-6 to 8 subjects will be treated with CAT-1004 per cohort.; Other Name: CAT-1004; Other: Placebo; Single dose oral administration of CAT1004 or placebo- 2 subjects treated with placebo per cohort.
Experimental: Cohort 6 / Dose level 6 (FE); Single dose orally (Under fed conditions) CAT-1004 Dose level 4 or placebo Subjects may be reenrolled from Cohort 4.	Drug: Drug; Single dose oral administration of CAT1004 or placebo-6 to 8 subjects will be treated with CAT-1004 per cohort.; Other Name: CAT-1004; Other: Placebo; Single dose oral administration of CAT1004 or placebo- 2 subjects treated with placebo per cohort.
Experimental: Cohort 7 / Dose level 7 (FE); Single dose orally (Under fed conditions)CAT-1004 Dose level 5 or placebo Subjects may be reenrolled from Cohort 5.	Drug: Drug; Single dose oral administration of CAT1004 or placebo-6 to 8 subjects will be treated with CAT-1004 per cohort.; Other Name: CAT-1004; Other: Placebo; Single dose oral administration of CAT1004 or placebo- 2 subjects treated with placebo per cohort.

Outcome Measures

Primary Outcome Measures :

1. Safety [ Time Frame: Change from Baseline versus Day-1 though 72 hrs post dose and EOT/FU ]
   Safety Endpoints: Laboratory evaluations including hematology, chemistry, coagulation and urinalysis, physical examinations, AEs, serious AEs (SAEs), ECGs, and vital signs.

Secondary Outcome Measures :

1. Pharmacokinetic Profile [ Time Frame: Plasma blood samples through 72 hrs, urine collections through 48 hrs ]
   The following noncompartmental PK parameters will be calculated: area under the concentration-time curve from time 0 extrapolated to infinity (AUCinf), area under concentration-time curve from time 0 to time of last quantifiable concentration (AUClast), maximum observed plasma concentration (Cmax), time to first occurrence of Cmax (Tmax), terminal phase elimination half-life (t½), apparent oral clearance (CL/F), and volume of distribution during the terminal phase (Vz/F). Additional PK parameters may be calculated if deemed appropriate.

Eligibility Criteria

• Ages Eligible for Study: 19 Years to 55 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Key Inclusion Criteria:

1. In good health.
2. Age: 19 to 55 years inclusive at Screening.

3. 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.
4. BMI: 18 to 30 kg/m2 at Screening.

Key Exclusion Criteria:

1. Clinically significant abnormalities in physical examination or vital signs.
2. Clinically significant electrocardiogram (ECG) abnormalities as assessed by the investigator.
3. Clinically significant screening laboratory result as assessed by the Investigator.
4. 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.
5. History or presence of malignancy with the past 5 years.
6. 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).
7. 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.
8. Any significant blood loss within 60 days prior to screening, e.g. blood donation, participation in study with multiple blood draws, etc.
9. 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.
10. A suspected allergy or sensitivity to CAT-1004 or excipients based upon known allergies to excipients or compounds of a similar class.
11. Any clinically significant systemic infection within 3 weeks prior to screening.
12. Use of prescription medications within 30 days of screening.

Contacts and Locations

Locations

United States, Nebraska

Celerion Clinical Research Unit

Lincoln, Nebraska, United States, 68502

Sponsors and Collaborators

Catabasis Pharmaceuticals

Investigators

• Principal Investigator: Scott Rasmussen, MD; Celerion

More Information

• Responsible Party: Catabasis Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT01440166
• Other Study ID Numbers: CAT-1004-101
• First Posted: September 26, 2011
• Last Update Posted: February 6, 2012
• Last Verified: February 2012

Keywords provided by Catabasis Pharmaceuticals:

Human healthy volunteers