Evaluation of Cross-Linked Polyelectrolyte (CLP) in Healthy Volunteers

Sorbent Therapeutics

Status and phase: Completed; Phase 1

Conditions: Basic Science: Safety, Tolerability, Efficacy of CLP

Treatments: Drug: Cross-Linked Polyelectrolyte (CLP)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01944007

CTST-5

Details and patient eligibility

About

This is a dose-escalation study to determine the effect of CLP in normal healthy volunteers.

Enrollment: 25 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy males or females between the ages of 18 and 70 years
• Body mass index (BMI) between 18 and 32 kg/m^2, inclusive
• Females could not be pregnant or breast feeding and had to be using birth control

Exclusion criteria

• Positive drug screen for substances of abuse
• Positive results for HIV, hepatitis B, or hepatitis C
• Screening 12-lead ECG demonstrating QTc interval >430 msec for males and >450 msec for females, or any cardiac rhythm disorder considered by the Investigator to be clinically relevant

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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25 participants in 4 patient groups

CLP 15 g Fed

Experimental group

Description:

Cross-Linked Polyelectrolyte (CLP) Study medication delivered q.i.d just before each of 4 standardized meals/snack

Treatment:

Drug: Cross-Linked Polyelectrolyte (CLP)

CLP 25 g Fed

Experimental group

Description:

Cross-Linked Polyelectrolyte (CLP) Study medication delivered q.i.d just before each of 4 standardized meals/snack

Treatment:

Drug: Cross-Linked Polyelectrolyte (CLP)

CLP 7.5 g Fed

Experimental group

Description:

Cross-Linked Polyelectrolyte (CLP) Study medication delivered q.i.d just before each of 4 standardized meals/snack

Treatment:

Drug: Cross-Linked Polyelectrolyte (CLP)

CLP 15 g fasted

Experimental group

Description:

Cross-Linked Polyelectrolyte (CLP) Study medication delivered q.i.d 1 hour prior to 4 standardized meals/snack

Treatment:

Drug: Cross-Linked Polyelectrolyte (CLP)