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

NCT ID: NCT02436447

Last Updated: 2015-11-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2015-10-31

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Normal renal function

Group Type: EXPERIMENTAL

MTP-131

Intervention Type: DRUG

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

Mild renal impairment

Group Type: EXPERIMENTAL

MTP-131

Intervention Type: DRUG

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

Moderate renal impairment

Group Type: EXPERIMENTAL

MTP-131

Intervention Type: DRUG

MTP-131 administered as once-daily 1- hour intravenous infusion for 7 consecutive days in subjects with moderate renal impairment

Severe renal impairment

Group Type: EXPERIMENTAL

MTP-131

Intervention Type: DRUG

MTP-131 administered as once-daily 1- hour intravenous infusion for 7 consecutive days in subjects with severe renal impairment

Interventions

MTP-131

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

Intervention Type: DRUG

MTP-131

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

Intervention Type: DRUG

MTP-131

MTP-131 administered as once-daily 1- hour intravenous infusion for 7 consecutive days in subjects with moderate renal impairment

Intervention Type: DRUG

MTP-131

MTP-131 administered as once-daily 1- hour intravenous infusion for 7 consecutive days in subjects with severe renal impairment

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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:

1. 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.

2. 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).

3. 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.

Exclusion Criteria

• 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.

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

Sponsors

Stealth BioTherapeutics Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Maimi, Florida, United States

Countries

United States

Other Identifiers

SPICP-101

Identifier Type: -

Identifier Source: org_study_id