A Phase 1 Study Investigating the Safety and Pharmacokinetics of Repeat-dose Intravenous Infusion of MTP-131 in Subjects With Impaired Renal Function

NCT02436447 | Completed Phase 1

• 1 other identifier: SPICP-101
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a Phase 1, open-label, parallel group, multiple dose study, in subjects over 18 years, to evaluate the safety, tolerability, and pharmacokinetics of one-hour intravenous infusion of MTP-131 administered for 7 consecutive days. Twenty-four subjects are planned to be enrolled into 4 cohorts of varying renal function, with each cohort consisting of 6 subjects.

Conditions

Normal and Impaired Renal Function

Keywords

Renal Impairment, Renal function, MTP-131, Bendavia™

Outcome Measures

Primary Outcomes (1)

• Mean peak plasma concentration (Cmax) of MTP-131 (ng/ml) in each cohort

  Assessed up to Day 14

Secondary Outcomes (1)

• Incidence of Adverse Events

  Assessed up to Day 14

Study Arms (4)

Normal renal function

EXPERIMENTAL

Drug: MTP-131

Mild renal impairment

EXPERIMENTAL

Drug: MTP-131

Moderate renal impairment

EXPERIMENTAL

Drug: MTP-131

Severe renal impairment

EXPERIMENTAL

Drug: MTP-131

Interventions

MTP-131 DRUG

MTP-131 administered as once-daily 1- hour intravenous infusion for 7 consecutive days in subjects with normal renal function.

Normal renal function

Eligibility Criteria

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

You may qualify if:

• Subject is ≥18 years-of-age at the Screening Visit.
• Subject has signed an ICF before any study specific procedures are performed.
• Subjects selected for each cohort must satisfy the following creatinine clearance (CLCR) criteria (as determined by 24 hour urine collection and analysis):
• Cohort 1 - Normal Renal Function, 24 hour CLCR ≥ 90 mL/min
• Cohort 2 - Mild renal impairment, 24 hour CLCR ≥ 60-89 mL/min
• Cohort 3 - Moderate renal impairment, 24 hour CLCR ≥ 30-59 mL/min
• Cohort 4 - Severe renal impairment, 24 hour CLCR \<30 not requiring dialysis
• Have a history of stable renal impairment as determined by standard estimated creatinine clearance methodology (at least 1 month within the same descriptive cohort) and be in a stable physical condition based on findings of medical history.
• Women of childbearing potential must agree to use 1 of the following methods of birth control from the date they sign the ICF until two months after the last dose of study drug:
• Abstinence, when it is in line with the preferred and usual lifestyle of the subject. Subject agrees to use an acceptable method of contraception should they become sexually active.
• Maintenance of a monogamous relationship with a male partner who has been surgically sterilized by vasectomy (the vasectomy procedure must have been conducted at least 60 days prior to the Screening Visit or confirmed via sperm analysis).
• Barrier method (e.g., condom or occlusive cap) with spermicidal foam/gel/film/cream AND either hormonal contraception (oral, implanted, or injectable) or an intrauterine device or system.

You may not qualify if:

• Subject has history of any concurrent medical condition which, in the opinion of the investigator, significantly increases the potential risks associated with administration of MTP-131 or any other aspect of study participation, with the exception of renal impairment.
• Female subjects who are pregnant, planning to become pregnant, or lactating.
• Subject has history of cancer (with the exception of non-melanoma skin cancer), unless the subject has documentation of completed curative treatment
• Subject has history of renal transplantation.
• Subject has active inflammatory renal disease.
• Subject has a history of histamine intolerance (e.g., a known deficiency of endogenous or exogenous histamine degradation).
• Subject is currently receiving treatment with chemotherapeutic agents or immunosuppressant agents.
• Subject has positive serology for HIV 1, HIV 2, HBsAg or HCV.
• Subject has donated or received blood or blood products within the past 30 days.
• Subject participated in a clinical study involving investigational product within 30 days prior to the planned date of study drug administration.
• Subject has a history of clinically significant hypersensitivity or allergy to any of the excipients contained in the study drug.
• Subject has a history of active alcoholism or drug addiction during the year before the Screening Visit.

Sponsors & Collaborators

• Stealth BioTherapeutics Inc.: lead

Study Sites (1)

Unknown Facility

Maimi, Florida, United States

Location

MeSH Terms

Conditions

Renal Insufficiency

Interventions

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

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2015
• First Posted: May 6, 2015
• Study Start: May 1, 2015
• Primary Completion: July 1, 2015
• Study Completion: October 1, 2015
• Last Updated: November 18, 2015

Record last verified: 2015-11

Locations

US (1)