Basic Science: Safety, Tolerability, Efficacy of CLP
Conditions
Keywords
CLP
Brief summary
This is a dose-escalation study to determine the effect of CLP in normal healthy volunteers.
Interventions
CLP was administered orally, in capsules, for 9 consecutive days.
Sponsors
Sorbent Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Net Sodium Balance | Days 5 - 9 | Daily net sodium balance was calculated based on dietary and fluid intake, urinary and fecal output and emesis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Fecal Weight | Days 1-9 | Total fecal weight throughout 9-day treatment period, and mean fecal weights (daily avg. of Days 5-9) |
| Net Balance of Potassium, Magnesium, Calcium, and Phosphorous | Days 5-9 | The net balance of cations was calculated based on dietary and fluid intake, urinary and fecal output, and emesis. |
| Fecal content and concentration of sodium, potassium, magnesium, calcium, phosphorous, iron, zinc, and copper | Days 5-9 | — |
| Urine content and concentration of sodium, potassium, magnesium, calcium, and phosphorous | Days 5-9 | — |
| Serum concentrations of sodium, potassium, magnesium, calcium, and phosphorous | Days 5-9 | — |
Countries
United States
Outcome results
None listed