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

NCT01115920 | Completed Phase 1 DMC

• 1 other identifier: SPIRI-101
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Treatment emergent adverse events in treatment group versus placebo group

  Safety assessments including vital signs, physical exam,12-lead ECG, serum chemistry, hematology, and urinalysis will be collected the day prior to and for 7 days following study drug infusion. These parameters will be assessed for clinically significant abnormalities.

  7 days

Secondary Outcomes (1)

• Pharmacokinetics of MTP-131 including Css, Cmax, tmax, t½, AUC and dose proportionality.

  Pre-infusion through 32 hours post infusion

Study Arms (5)

Arm 1

EXPERIMENTAL

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

Drug: MTP-131 (Bendavia™)

Arm 2

EXPERIMENTAL

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

Drug: MTP-131 (Bendavia™)

Arm 3

EXPERIMENTAL

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

Drug: MTP-131 (Bendavia™)

Arm 4

EXPERIMENTAL

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

Drug: MTP-131 (Bendavia™)

Arm 5

EXPERIMENTAL

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

Drug: MTP-131 (Bendavia™)

Interventions

MTP-131 (Bendavia™) DRUG

Single 4 hour intravenous infusion

Arm 1; Arm 2; Arm 3; Arm 4; Arm 5

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:

Sponsors & Collaborators

• Stealth BioTherapeutics Inc.: lead

Study Sites (1)

Clinical Pharmacology of Miami, Inc.

Miami, Florida, 33014-3616, United States

Location

MeSH Terms

Interventions

arginyl-2,'6'-dimethyltyrosyl-lysyl-phenylalaninamide

Study Officials

• Kenneth Lasseter, MD

  Clinical Pharmacology of Miami, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: April 30, 2010
• First Posted: May 4, 2010
• Study Start: May 1, 2010
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: November 18, 2010

Record last verified: 2010-11

Locations

US (1)