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

This study has been completed.
Sponsor:
Information provided by:
Stealth Peptides, Inc.
ClinicalTrials.gov Identifier:
NCT01115920
First received: April 30, 2010
Last updated: November 17, 2010
Last verified: November 2010
  Purpose

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.


Condition Intervention Phase
Healthy
Drug: MTP-131 (Bendavia™)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase I Study in Healthy Male and Healthy Female Subjects to Characterize the Safety, Tolerability, and Pharmacokinetics of Intravenous Infusion of MTP-131 (Bendavia™) Using a Randomized, Double-Blind, Placebo-Controlled, Parallel Group Design

Further study details as provided by Stealth Peptides, Inc.:

Primary Outcome Measures:
  • Treatment emergent adverse events in treatment group versus placebo group [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Pharmacokinetics of MTP-131 including Css, Cmax, tmax, t½, AUC and dose proportionality. [ Time Frame: Pre-infusion through 32 hours post infusion ] [ Designated as safety issue: No ]
    Css (plasma steady state concentration), Cmax (observed peak plasma concentration), tmax (time of observed peak), AUC0-t (area under the plasma concentration time curve from time zero to the last quantifiable timepoint), AUC0-∞ (area under the plasma concentration time curve from time zero to infinity), λz (terminal [or elimination rate] phase rate constant), t½ (terminal half-life), CL (plasma clearance) and Vss (volume of distribution at steady state) will be determined for MTP-131. Ae (amount excreted in the urine) and CLr (renal clearance) may also be evaluated.


Enrollment: 40
Study Start Date: May 2010
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
Cohort 1, Dose 0.010 mg/kg/hr Active (6), Placebo (2), Total Subjects (8)
Drug: MTP-131 (Bendavia™)
Single 4 hour intravenous infusion
Experimental: Arm 2
Cohort 2, Dose 0.025 mg/kg/hr Active (6), Placebo (2), Total Subjects (8)
Drug: MTP-131 (Bendavia™)
Single 4 hour intravenous infusion
Experimental: Arm 3
Cohort 3, Dose 0.050 mg/kg/hr Active (6), Placebo (2), Total Subjects (8)
Drug: MTP-131 (Bendavia™)
Single 4 hour intravenous infusion
Experimental: Arm 4
Cohort 4, Dose 0.100 mg/kg/hr Active (6), Placebo (2), Total Subjects (8)
Drug: MTP-131 (Bendavia™)
Single 4 hour intravenous infusion
Experimental: Arm 5
Cohort 5, Dose 0.250 mg/kg/hr Active (6), Placebo (2), Total Subjects (8)
Drug: MTP-131 (Bendavia™)
Single 4 hour intravenous infusion

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01115920

Locations
United States, Florida
Clinical Pharmacology of Miami, Inc.
Miami, Florida, United States, 33014-3616
Sponsors and Collaborators
Stealth Peptides, Inc.
Investigators
Principal Investigator: Kenneth Lasseter, MD Clinical Pharmacology of Miami, Inc.
  More Information

No publications provided

Responsible Party: Richard Straube, MD, Chief Medical Officer, Stealth Peptides, Inc.
ClinicalTrials.gov Identifier: NCT01115920     History of Changes
Other Study ID Numbers: SPIRI-101
Study First Received: April 30, 2010
Last Updated: November 17, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Stealth Peptides, Inc.:
Drug Safety
Clinical Trial, Phase I
Nontherapeutic Human Experimentation
Heading Pharmacokinetics
Phase I Safety and Tolerability

ClinicalTrials.gov processed this record on April 16, 2014