Study to Evaluate Safety, Tolerability, and Pharmacokinetics (PK) of Intravenous (IV) Infusion of MTP-131 (Bendavia™) in Healthy Adults

NCT ID: NCT01115920

Last Updated: 2010-11-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-05-31
• Study Completion Date: 2010-09-30

Brief Summary

This is the first study of MTP-131 (Bendavia™) in humans. The objective of this study is to evaluate the safety, tolerability, and pharmacokinetics of escalating single intravenous infusion doses of MTP-131.

Detailed Description

The primary objective of the study is to evaluate the safety and tolerability of MTP-131 in healthy volunteers following a single intravenous infusion. The secondary objective is to evaluate the pharmacokinetics of MTP-131. This is a double-blind, placebo-controlled, randomized trial. A total of 40 eligible subjects will be enrolled and randomized in a 3:1 active to placebo ratio for a total of 5 treatment groups of 8 volunteers. As far as is logistically possible, each treatment group will have similar numbers of male and female volunteers. After the last subject for each cohort has completed the day 3 clinical assessment and no stopping rules have been met according to Safety Review Board decision, the next cohort will commence.

Conditions

Healthy

Keywords

Drug Safety; Clinical Trial, Phase I; Nontherapeutic Human Experimentation; Heading Pharmacokinetics; Phase I Safety and Tolerability

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Arm 1

Cohort 1, Dose 0.010 mg/kg/hr Active (6), Placebo (2), Total Subjects (8)

Group Type: EXPERIMENTAL

MTP-131 (Bendavia™)

Intervention Type: DRUG

Single 4 hour intravenous infusion

Arm 2

Cohort 2, Dose 0.025 mg/kg/hr Active (6), Placebo (2), Total Subjects (8)

Group Type: EXPERIMENTAL

MTP-131 (Bendavia™)

Intervention Type: DRUG

Single 4 hour intravenous infusion

Arm 3

Cohort 3, Dose 0.050 mg/kg/hr Active (6), Placebo (2), Total Subjects (8)

Group Type: EXPERIMENTAL

MTP-131 (Bendavia™)

Intervention Type: DRUG

Single 4 hour intravenous infusion

Arm 4

Cohort 4, Dose 0.100 mg/kg/hr Active (6), Placebo (2), Total Subjects (8)

Group Type: EXPERIMENTAL

MTP-131 (Bendavia™)

Intervention Type: DRUG

Single 4 hour intravenous infusion

Arm 5

Cohort 5, Dose 0.250 mg/kg/hr Active (6), Placebo (2), Total Subjects (8)

Group Type: EXPERIMENTAL

MTP-131 (Bendavia™)

Intervention Type: DRUG

Single 4 hour intravenous infusion

Interventions

MTP-131 (Bendavia™)

Single 4 hour intravenous infusion

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Healthy adult males or females age ≥18 years of age with signed informed consent.
• Women who are not post-menopausal or surgically sterile must have a negative serum pregnancy test at screening and within 24 hours of treatment and who agree to use effective contraception for 30 days following the study.

Exclusion Criteria

• Clinically significant laboratory abnormalities,
• Clinically significant abnormalities on physical examination,
• BMI of less than 18 kg/m2 or greater than 32 kg/m2,
• Any disease or condition that might compromise the cardiovascular, hematological, renal, hepatic, pulmonary (including chronic asthma), endocrine (e.g., diabetes), central nervous, or gastrointestinal (including an ulcer) systems,
• History of seizures or epilepsy,
• History of serious mental illness,
• Participant in unrelated research involving investigational product within 30 days before planned date of drug administration,
• Positive serology for HIV 1, HIV 2, HBsAg, or HCV,
• Fever greater than 37.5°C at the time of planned dosing,
• Suspicion of or recent history of alcohol or substance abuse,
• Donated blood or blood products within the past 30 days,
• Women who are pregnant or breastfeeding,
• Employee or family member of the investigational site, and
• Subjects who currently smoke cigarettes, cigars, pipes or chew tobacco products,
• Subjects who are either unwilling to agree to refrain from use or found to be using:

1. Alcohol, caffeine, xanthine-containing food or beverages, nicotine products and over-the-counter medications with the exception of Tylenol from 24 hours prior to dosing and throughout the confinement period

2. Prescription medications from 14 days prior to and 7 days post treatment

3. Oral contraceptives without concomitant use of double-barrier contraceptives (condom, diaphragm with spermicide) for a period of 7 days prior to and 30 days post treatment

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Stealth BioTherapeutics Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Stealth Peptides, Inc.

Principal Investigators

Kenneth Lasseter, MD

Role: PRINCIPAL_INVESTIGATOR

Clinical Pharmacology of Miami, Inc.

Locations

Clinical Pharmacology of Miami, Inc.

Miami, Florida, United States

Countries

United States

Other Identifiers

SPIRI-101

Identifier Type: -

Identifier Source: org_study_id