A Phase 1, Open-Label Study to Assess the Single-Dose Pharmacokinetics of Eravacycline in Subjects With End Stage Renal Disease and Healthy Subjects

NCT02135276 | Completed Phase 1

• 1 other identifier: TP-434-014
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a multi-center, open-label clinical study to assess the single-dose PK of eravacycline in subjects with renal impairment and healthy subjects conducted at approximately 2 sites in the United States. This study includes an up to 21-day Screening Period, a 5-day Treatment Period, and an End of Study Visit occurring approximately 2 weeks (±2 days) after study drug administration. Approximately 12 subjects will be enrolled: 6 subjects with ESRD and 6 healthy subjects with normal renal function. Healthy subjects will be matched to renally impaired subjects in gender, age, and body mass index (BMI). All subjects will be administered a single IV dose of eravacycline (1.5 mg/kg).

Conditions

End Stage Renal Disease

Outcome Measures

Primary Outcomes (1)

• Assess the pharmacokinetic (PK) profile of eravacycline after administration of a single intravenous (IV) dose (1.5 mg/kg) to subjects with end stage renal disease (ESRD) compared with normal healthy subjects

  5 days

Secondary Outcomes (1)

• Determine the safety and tolerability of eravacycline after administration of a single IV dose (1.5 mg/kg) in subjects with ESRD compared with normal healthy subjects

  5 days

Study Arms (2)

End stage renal disease (ESRD) subjects

EXPERIMENTAL

A single dose of intravenous eravacycline (1.5 mg/kg) administered over 60 minutes

Drug: eravacycline

Normal healthy subjects

EXPERIMENTAL

A single dose of intravenous eravacycline (1.5 mg/kg) administered over 60 minutes

Drug: eravacycline

Interventions

eravacycline DRUG

All subjects will receive s single dose of intravenous eravacycline (1.5 mg/kg) administered over 60 minutes on Day 1. This study includes an up to 21-day Screening Period, a 5-day Treatment Period, and an End of Study Visit occurring approximately 2 weeks (±2 days) after study drug administration. Approximately 12 subjects will be enrolled: 6 subjects with ESRD and 6 healthy subjects with normal renal function. Healthy subjects will be matched to renally impaired subjects in gender, age, and body mass index (BMI).

Also known as: TP-434

End stage renal disease (ESRD) subjects; Normal healthy subjects

Eligibility Criteria

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

You may qualify if:

• Male or female subject aged 18 years at Screening;
• Eligible female subjects of childbearing potential with a non-sterilized male sexual partner must agree to use 2 medically accepted, effective methods of birth control (eg, hormonal contraceptive, barrier contraceptive with additional spermicide, or an intrauterine device) beginning \>30 days prior to study drug administration and continuing until 7 days after the end of the study. Female subjects who are postmenopausal must have been postmenopausal for \>1 year if they wish not to use contraceptives. If postmenopausal status is questionable, the subject's follicle stimulating hormone level must be checked and must be elevated and consistent with postmenopausal levels (ie, \>40 IU/L); otherwise these subjects must agree to use contraceptives listed above;
• Male subjects with sexual partners of childbearing potential must agree to use a barrier contraceptive from the time of study drug administration through 7 days after the end of the study;
• Female subjects of childbearing potential (including females with questionable postmenopausal status) must have a negative pregnancy test prior to dosing (Screening and Day -1);
• Has a body mass index of 17 kg/m2 to 40 kg/m2, inclusive;
• Has negative alcohol and illicit drug screens;
• Has a negative screen for Human Immunodeficiency Virus;
• Is able to understand and comply with study procedures and give written informed consent according to institutional and regulatory guidelines;
• Subjects with ESRD renal impairment:
• Has a positive diagnosis of ESRD maintained on hemodialysis treatments 3 times a week for at least 3 months with a minimum Kt/V of 1.2;
• Is otherwise considered healthy except for abnormalities consistent with underlying ESRD as determined by past medical history, physical examination, vital signs, and laboratory tests at Screening;
• Healthy subjects without renal impairment:
• Must be in good health as determined by screening medical history, physical examination, vital signs, blood chemistry, hematology, glucose, and coagulation performance at Screening;
• Has a negative screen for hepatitis B (HBV) and hepatitis C (HCV); and
• Should be matched to a subject with renal impairment in gender, age, and BMI.

You may not qualify if:

• Female subjects who are pregnant, breastfeeding, or planning to become pregnant during the course of the study;
• Has a history or current evidence of clinically significant hematological, hepatic, endocrine, pulmonary, gastrointestinal, cardiovascular, neurological, or psychiatric disease that may pose a significant safety risk or diminish a subject's ability to undergo all study procedures and assessments;
• Use of another investigational drug or device within 30 days prior to receiving eravacycline (TP-434), or within at least 5 half-lives of the previous investigational drug, whichever is longer;
• Has a history of alcoholism or drug abuse within 6 months prior to dosing;
• Has urinary incontinence;
• Has a typical weekly alcohol consumption of 14 alcoholic drinks. One drink is defined as 1 glass of beer (approximately 10 oz to 12 oz) or 1 can (12 oz) of beer, 1 glass of wine (approximately 4 oz to 5 oz), or 1 glass of distilled spirits (hard liquor) containing 1 oz of the liquor (1 oz of liquid is approximately 30 mL);
• Use of alcohol within 48 hours prior to admission until completion of the final PK draw on Day 5;
• Has had a major surgical procedure within 3 months prior to administration of study drug;
• Has known allergies to tetracycline antibiotics or related compounds, or a history of multiple adverse drug allergies of any origin;
• Has inadequate venous access;
• Donated \>500 mL of blood within 2 months prior to Screening;
• Is a member of the clinical site personnel directly affiliated with this study;
• Has poor mental function or any other reason to expect subject difficulty in complying with the requirements of the study in the judgment of the investigator;
• Has any surgical or medical condition which might significantly alter the absorption, distribution, or excretion of the drug;
• Fails to comply with protocol requirements, or whose further participation in the study would be unsuitable to the subject, as determined by the investigator;

Sponsors & Collaborators

• Tetraphase Pharmaceuticals, Inc: lead

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

eravacycline

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2014
• First Posted: May 9, 2014
• Study Start: December 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: May 1, 2014
• Last Updated: December 17, 2021

Record last verified: 2021-12