Evaluation of Four Different Dosing Regimens of Cross-Linked Polyelectrolyte (CLP) in Healthy Volunteers

Sorbent Therapeutics

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Cross-Linked Polyelectrolyte (CLP)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02079233

CTST-16

Details and patient eligibility

About

This is a study to determine the effect of four different dosing regimens of CLP in normal healthy volunteers.

Enrollment: 25 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy volunteer is ≥ 18 years of age with BMI of 18-32
• Females could not be pregnant or breast feeding and had to be using birth control
• Must have regular bowel habits, typically producing at least 1 daily bowel movement

Exclusion criteria

• 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
• History or presence of gastrointestinal conditions
• Positive drug screen for substances of abuse
• Positive results for HIV, hepatitis B, or hepatitis C

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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25 participants in 4 patient groups

CLP 15 g QD

Experimental group

Description:

Cross-Linked Polyelectrolyte (CLP) study medication delivered immediately before bedtime

Treatment:

Drug: Cross-Linked Polyelectrolyte (CLP)

CLP 7.5 g BID

Experimental group

Description:

Cross-Linked Polyelectrolyte (CLP) Study medication delivered b.i.d. one hour before breakfast and dinner

Treatment:

Drug: Cross-Linked Polyelectrolyte (CLP)

CLP 5 g TID

Experimental group

Description:

Cross-Linked Polyelectrolyte (CLP) Study medication delivered t.i.d. one hour before breakfast, lunch and dinner

Treatment:

Drug: Cross-Linked Polyelectrolyte (CLP)

CLP 3.75 g QID

Experimental group

Description:

Cross-Linked Polyelectrolyte (CLP) Study medication delivered q.i.d on hour before breakfast, lunch, dinner and immediately before bedtime

Treatment:

Drug: Cross-Linked Polyelectrolyte (CLP)