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

NCT ID: NCT01440166

Last Updated: 2012-02-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2012-01-31

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: DOUBLE

Study Groups

Cohort 1 / Dose level 1

Single dose orally: CAT-1004 Dose level 1 or placebo

Group Type: EXPERIMENTAL

Drug

Intervention Type: DRUG

Single dose oral administration of CAT1004 or placebo-6 to 8 subjects will be treated with CAT-1004 per cohort.

Placebo

Intervention Type: OTHER

Single dose oral administration of CAT1004 or placebo- 2 subjects treated with placebo per cohort.

Cohort 2 / Dose level 2

Single dose orally: CAT-1004 Dose level 2 or placebo

Group Type: EXPERIMENTAL

Drug

Intervention Type: DRUG

Single dose oral administration of CAT1004 or placebo-6 to 8 subjects will be treated with CAT-1004 per cohort.

Placebo

Intervention Type: OTHER

Single dose oral administration of CAT1004 or placebo- 2 subjects treated with placebo per cohort.

Cohort 3 /Dose level 3

Single dose orally: CAT-1004 Dose level 3 or placebo

Group Type: EXPERIMENTAL

Drug

Intervention Type: DRUG

Single dose oral administration of CAT1004 or placebo-6 to 8 subjects will be treated with CAT-1004 per cohort.

Placebo

Intervention Type: OTHER

Single dose oral administration of CAT1004 or placebo- 2 subjects treated with placebo per cohort.

Cohort 4/ Dose level 4

Single dose orally: CAT-1004 Dose level 4 or placebo

Group Type: EXPERIMENTAL

Drug

Intervention Type: DRUG

Single dose oral administration of CAT1004 or placebo-6 to 8 subjects will be treated with CAT-1004 per cohort.

Placebo

Intervention Type: OTHER

Single dose oral administration of CAT1004 or placebo- 2 subjects treated with placebo per cohort.

Cohort 5/ Dose level 5

Single dose orally: CAT-1004 Dose level 5 or placebo

Group Type: EXPERIMENTAL

Drug

Intervention Type: DRUG

Single dose oral administration of CAT1004 or placebo-6 to 8 subjects will be treated with CAT-1004 per cohort.

Placebo

Intervention Type: OTHER

Single dose oral administration of CAT1004 or placebo- 2 subjects treated with placebo per cohort.

Cohort 2/ Dose level 2 ( FE)

Single dose orally (Under fed conditions): CAT-1004 Dose level 2 or placebo

Group Type: EXPERIMENTAL

Drug

Intervention Type: DRUG

Single dose oral administration of CAT1004 or placebo-6 to 8 subjects will be treated with CAT-1004 per cohort.

Placebo

Intervention Type: OTHER

Single dose oral administration of CAT1004 or placebo- 2 subjects treated with placebo per cohort.

Cohort 3/ Dose level 3 (FE)

Single dose orally (Under fed conditions): CAT-1004 Dose level 3 or placebo

Group Type: EXPERIMENTAL

Drug

Intervention Type: DRUG

Single dose oral administration of CAT1004 or placebo-6 to 8 subjects will be treated with CAT-1004 per cohort.

Placebo

Intervention Type: OTHER

Single dose oral administration of CAT1004 or placebo- 2 subjects treated with placebo per cohort.

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.

Group Type: EXPERIMENTAL

Drug

Intervention Type: DRUG

Single dose oral administration of CAT1004 or placebo-6 to 8 subjects will be treated with CAT-1004 per cohort.

Placebo

Intervention Type: OTHER

Single dose oral administration of CAT1004 or placebo- 2 subjects treated with placebo per cohort.

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.

Group Type: EXPERIMENTAL

Drug

Intervention Type: DRUG

Single dose oral administration of CAT1004 or placebo-6 to 8 subjects will be treated with CAT-1004 per cohort.

Placebo

Intervention Type: OTHER

Single dose oral administration of CAT1004 or placebo- 2 subjects treated with placebo per cohort.

Interventions

Drug

Single dose oral administration of CAT1004 or placebo-6 to 8 subjects will be treated with CAT-1004 per cohort.

Intervention Type: DRUG

Placebo

Single dose oral administration of CAT1004 or placebo- 2 subjects treated with placebo per cohort.

Intervention Type: OTHER

Other Intervention Names

CAT-1004

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Catabasis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Scott Rasmussen, MD

Role: PRINCIPAL_INVESTIGATOR

Celerion

Locations

Celerion Clinical Research Unit

Lincoln, Nebraska, United States

Countries

United States

Other Identifiers

CAT-1004-101

Identifier Type: -

Identifier Source: org_study_id