PK Study of Intranasal RX0041-002 in Subjects With Severe Renal Impairment and Normal Renal Function

NCT02775955 | Completed Phase 1

• 1 other identifier: CTS2015013
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to evaluate the potential effect of renal impairment on the systemic pharmacokinetics of acute Intranasal RX0041-002. The secondary objective is to evaluate the safety and tolerability of acute Intranasal RX0041-002 in subjects with normal renal function and severe renal impairment.

Conditions

Healthy

Keywords

Pharmacokinetics

Outcome Measures

Primary Outcomes (2)

• Peak Plasma Concentration (Cmax)

  32 Hours

• Area under the plasma concentration versus time curve (AUC)

  32 Hours

Study Arms (1)

RX0041-002

EXPERIMENTAL

Active

Drug: RX0041

Interventions

RX0041 DRUG

Active

Also known as: 0041

RX0041-002

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.
• Greater than or equal to 18 years of age and able to understand and comply with protocol requirements, provide written informed consent and HIPPA authorization; ± 10 years for individual age-matched controls.
• Females (if of child-bearing potential and sexually active) and males (if sexually active with a partner of child-bearing potential) who agree to use a medically acceptable and effective birth control method from the first dose and for 8 days following administration of study drug. Medically acceptable methods of contraception that may be used by the participant and/or his/her partner include abstinence, birth control pills or patches, diaphragm, intrauterine device (IUD), condom, surgical sterilization, and progestin implant or injection. Prohibited methods include: the rhythm method or withdrawal.
• BMI ≥ 18 ≤ 42 (see Appendix); ± 20% for BMI-matched controls
• In general, good health aside from renal disease and associated conditions as ascertained by physical examination (PE) including measurement of supine and standing vital signs, medical history, clinical laboratory studies, and 12-lead electrocardiogram (ECG).
• For assignment to the normal renal function (control) group, subjects must have an eGFR ≥ 90 mL/min/1.73m2 at screening. Assignment to the severe renal impairment group will be based upon an eGFR of 15-29 mL/min/1.73m2 at screening.
• Clinical laboratory values within the laboratory's stated normal range; if not within this range, they must be without any clinical significance.

You may not qualify if:

• Concurrent use of medications known to affect the elimination of serum creatinine (eg, trimethoprim/sulfamethoxazole \[Bactrim®\] or cimetidine \[Tagamet®\]) and competitors of renal tubular secretion (eg, probenecid) within 30 days prior to the first dose of study drug.
• Presence of significant gastrointestinal, liver or any other conditions known to interfere with the absorption, distribution, metabolism or excretion of drugs or known to potentiate or predispose to undesired effects.
• Use of any enzyme-modifying drugs, including strong inhibitors of cytochrome P450 (CYP) enzymes (such as cimetidine, fluoxetine, quinidine, erythromycin, ciprofloxacin, fluconazole, ketoconazole, diltiazem and HIV antivirals) and strong inducers of CYP enzymes (such as barbiturates, carbamazepine, glucocorticoids, phenytoin, rifampin and St John's Wort), in the previous 28 days before day 1 of this study.
• The use of amphetamines, methylphenidate or other stimulant prescription and nonprescription products such as pseudoephedrine, bronchial inhalers containing sympathomimetics (epinephrine or other beta-receptor agonist) or herbal products in the 7 days prior to screening or has a need to use these drugs during the course of the study.
• Use of any selective serotonin and norepinephrine reuptake inhibitorsserotonin-specific reuptake inhibitors antidepressants or tricyclic antidepressant up to7 days or 5 half-lives (whichever is longer) prior to screening or has a need to use these drugs during the screening period and throughout the time period of the trial.
• Use of Monoamine oxiadse inhibitors drugs up to 14 days prior to screening or has a need to use these drugs during the screening period and throughout the time period of the trial.
• History of hepatitis
• Elevated aspartate aminotransferase/alanine aminotransferase/bilirubin,
• HIV
• Excessive use of alcohol/tobacco/caffeine
• Less than 18 years of age.
• Has previously received study drug.
• Has a history of abuse of controlled substances, nasal or otherwise, or has damage to the nasal space, that in the opinion of the investigator might interfere with the ability to absorb RX0041-002.
• Has severely traumatized mucosa or sepsis in the nasal cavity.
• Has participated in an investigational study or received an investigational drug within 30 days preceding the randomization.

Sponsors & Collaborators

• Pharmaceutical Project Solutions, Inc.: lead
• Cognitive Research Corporation: collaborator

Study Sites (1)

Comprehensive Clinical Researc

Berlin, New Jersey, 08009, United States

Location

MeSH Terms

Interventions

FG 0041

Study Design

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

Study Record Dates

• First Submitted: March 23, 2016
• First Posted: May 18, 2016
• Study Start: February 1, 2016
• Primary Completion: July 1, 2016
• Study Completion: October 1, 2016
• Last Updated: April 6, 2018

Record last verified: 2017-04

Locations

US (1)