Trial Outcomes & Findings for A Study to Evaluate the Effects of Renal Impairment on the Pharmacokinetics of ELX-02 (NCT NCT03776539)
NCT ID: NCT03776539
Last Updated: 2021-04-13
Results Overview
Area under the curve (AUC0-24) of ELX-02 plasma concentration following a single subcutaneous (SC) dose
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
24 participants
Primary outcome timeframe
0.25, 0.5, 0.75, 1, 2, 4, 6, 12, and 24 hours after dosing
Results posted on
2021-04-13
Participant Flow
All subjects were treated at medical clinics. Groups 1-2 Screening start: January 4, 2019 Screening end: 8 April 2019 Group 3 Screening start: 9 May 2019 Screening end: 17 June 2019 Group 4 Screening start: 26 June 2019 Screening end: 30 June 2019
Participant milestones
| Measure |
Mild Renal Impairment
eGFR 60 to 89 mL/min/1.73 m\^2
|
Moderate Renal Impairment
eGFR 30 to 59 mL/min/1.73 m\^2
|
Severe Renal Impairment
eGFR \<30 mL/min/1.73 m\^2, Not Requiring Dialysis
|
Healthy Volunteers
eGFR \>=90 mL/min/1.73 m\^2
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
6
|
6
|
|
Overall Study
COMPLETED
|
6
|
6
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Evaluate the Effects of Renal Impairment on the Pharmacokinetics of ELX-02
Baseline characteristics by cohort
| Measure |
Group 1
n=6 Participants
Mild Renal Impairment eGFR 60 to 89 mL/min/1.73 m\^2
|
Group 2
n=6 Participants
Moderate Renal Impairment eGFR 30 to 59 mL/min/1.73 m\^2
|
Group 3
n=6 Participants
Severe Renal Impairment eGFR \<30 mL/min/1.73 m\^2, Not Requiring Dialysis
|
Group 4
n=6 Participants
Healthy Volunteers eGFR \>=90 mL/min/1.73 m\^2
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
66.8 years
STANDARD_DEVIATION 5.9 • n=5 Participants
|
65.0 years
STANDARD_DEVIATION 10.4 • n=7 Participants
|
61.8 years
STANDARD_DEVIATION 8.2 • n=5 Participants
|
57.7 years
STANDARD_DEVIATION 2.1 • n=4 Participants
|
62.8 years
STANDARD_DEVIATION 7.7 • n=21 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
6 participants
n=7 Participants
|
6 participants
n=5 Participants
|
6 participants
n=4 Participants
|
24 participants
n=21 Participants
|
|
eGFR
|
74.72 mL/min/1.73 m2
STANDARD_DEVIATION 9.25 • n=5 Participants
|
40.07 mL/min/1.73 m2
STANDARD_DEVIATION 4.54 • n=7 Participants
|
16.92 mL/min/1.73 m2
STANDARD_DEVIATION 9.77 • n=5 Participants
|
100.25 mL/min/1.73 m2
STANDARD_DEVIATION 15.65 • n=4 Participants
|
57.99 mL/min/1.73 m2
STANDARD_DEVIATION 34.06 • n=21 Participants
|
PRIMARY outcome
Timeframe: 0.25, 0.5, 0.75, 1, 2, 4, 6, 12, and 24 hours after dosingArea under the curve (AUC0-24) of ELX-02 plasma concentration following a single subcutaneous (SC) dose
Outcome measures
| Measure |
Mild Renal Impairment
n=6 Participants
eGFR 60 to 89 mL/min/1.73 m\^2
|
Moderate Renal Impairment
n=6 Participants
eGFR 30 to 59 mL/min/1.73 m\^2
|
Severe Renal Impairment
n=6 Participants
eGFR \<30 mL/min/1.73 m\^2, Not Requiring Dialysis
|
Healthy Volunteers
n=6 Participants
eGFR \>=90 mL/min/1.73 m\^2
|
|---|---|---|---|---|
|
Pharmacokinetic Parameters- Plasma AUC0-24
|
16877.94 ng*h/mL
Standard Deviation 1714.57
|
32787.41 ng*h/mL
Standard Deviation 7410.46
|
64895.29 ng*h/mL
Standard Deviation 16967.68
|
15506.68 ng*h/mL
Standard Deviation 3444.66
|
PRIMARY outcome
Timeframe: 0.25, 0.5, 0.75, 1, 2, 4, 6, 12, 24, 36, 48, 72, and 168 (Day 8) hours after dosingPeak Plasma Concentration (Cmax) of ELX-02 following a single subcutaneous (SC) dose in subjects with normal renal function, mild, moderate, or severe renal impairment
Outcome measures
| Measure |
Mild Renal Impairment
n=6 Participants
eGFR 60 to 89 mL/min/1.73 m\^2
|
Moderate Renal Impairment
n=6 Participants
eGFR 30 to 59 mL/min/1.73 m\^2
|
Severe Renal Impairment
n=6 Participants
eGFR \<30 mL/min/1.73 m\^2, Not Requiring Dialysis
|
Healthy Volunteers
n=6 Participants
eGFR \>=90 mL/min/1.73 m\^2
|
|---|---|---|---|---|
|
Pharmacokinetic Parameters- Plasma Cmax
|
2993.33 ng/mL
Standard Deviation 280.33
|
3688.33 ng/mL
Standard Deviation 525.56
|
4273.33 ng/mL
Standard Deviation 947.49
|
2995.00 ng/mL
Standard Deviation 568.99
|
PRIMARY outcome
Timeframe: 0.25, 0.5, 0.75, 1, 2, 4, 6, 12, 24, 36, 48, 72, and 168 (Day 8) hours after dosingArea under the curve (AUC0-inf) of ELX-02 plasma concentration following a single subcutaneous (SC) dose
Outcome measures
| Measure |
Mild Renal Impairment
n=6 Participants
eGFR 60 to 89 mL/min/1.73 m\^2
|
Moderate Renal Impairment
n=6 Participants
eGFR 30 to 59 mL/min/1.73 m\^2
|
Severe Renal Impairment
n=6 Participants
eGFR \<30 mL/min/1.73 m\^2, Not Requiring Dialysis
|
Healthy Volunteers
n=6 Participants
eGFR \>=90 mL/min/1.73 m\^2
|
|---|---|---|---|---|
|
AUC0-inf
|
16997.41 h*ng/mL
Standard Deviation 1776.84
|
35179.57 h*ng/mL
Standard Deviation 9198.37
|
110925.53 h*ng/mL
Standard Deviation 49098.37
|
15214.30 h*ng/mL
Standard Deviation 2913.01
|
PRIMARY outcome
Timeframe: 0.25, 0.5, 0.75, 1, 2, 4, 6, 12, and 24 hours after dosing.Time to maximum concentration (Tmax) of ELX-02 plasma concentration following a single subcutaneous (SC) dose
Outcome measures
| Measure |
Mild Renal Impairment
n=6 Participants
eGFR 60 to 89 mL/min/1.73 m\^2
|
Moderate Renal Impairment
n=6 Participants
eGFR 30 to 59 mL/min/1.73 m\^2
|
Severe Renal Impairment
n=6 Participants
eGFR \<30 mL/min/1.73 m\^2, Not Requiring Dialysis
|
Healthy Volunteers
n=6 Participants
eGFR \>=90 mL/min/1.73 m\^2
|
|---|---|---|---|---|
|
Pharmacokinetic Parameters - Plasma Tmax
|
1.00 hour
Interval 0.75 to 2.0
|
1.00 hour
Interval 0.75 to 2.0
|
2.00 hour
Interval 1.0 to 6.0
|
1.50 hour
Interval 0.73 to 2.0
|
PRIMARY outcome
Timeframe: Pre-dose (first void in the morning of Day 1), 0-3, 3-6, 6-9, 9-12, 12-18, 18-24, 24-36, 36-48, and 48-72 hours post-doseCumulative amount of unchanged drug excreted into urine (Ae0-t) of ELX-02 following a single subcutaneous (SC) dose
Outcome measures
| Measure |
Mild Renal Impairment
n=6 Participants
eGFR 60 to 89 mL/min/1.73 m\^2
|
Moderate Renal Impairment
n=6 Participants
eGFR 30 to 59 mL/min/1.73 m\^2
|
Severe Renal Impairment
n=6 Participants
eGFR \<30 mL/min/1.73 m\^2, Not Requiring Dialysis
|
Healthy Volunteers
n=6 Participants
eGFR \>=90 mL/min/1.73 m\^2
|
|---|---|---|---|---|
|
Urine Pharmacokinetics Parameter - Ae0-t
|
61.50 mg
Standard Deviation 19.37
|
72.10 mg
Standard Deviation 26.45
|
54.86 mg
Standard Deviation 8.74
|
69.22 mg
Standard Deviation 17.70
|
PRIMARY outcome
Timeframe: Pre-dose (first void in the morning of Day 1), 0-3, 3-6, 6-9, 9-12, 12-18, 18-24, 24-36, 36-48, and 48-72 hours post-doseMaximum rate of urinary extraction (Rmax) of ELX-02 following a single subcutaneous (SC) dose
Outcome measures
| Measure |
Mild Renal Impairment
n=6 Participants
eGFR 60 to 89 mL/min/1.73 m\^2
|
Moderate Renal Impairment
n=6 Participants
eGFR 30 to 59 mL/min/1.73 m\^2
|
Severe Renal Impairment
n=6 Participants
eGFR \<30 mL/min/1.73 m\^2, Not Requiring Dialysis
|
Healthy Volunteers
n=6 Participants
eGFR \>=90 mL/min/1.73 m\^2
|
|---|---|---|---|---|
|
Urine Pharmacokinetic Parameter - Rmax
|
9.18 mg/h
Standard Deviation 2.91
|
8.06 mg/h
Standard Deviation 5.91
|
3.11 mg/h
Standard Deviation 1.81
|
12.09 mg/h
Standard Deviation 2.82
|
PRIMARY outcome
Timeframe: 1-8 daysTEAEs are undesirable events not present prior to medical treatment, or an already present event that worsens either in intensity or frequency following the study treatment
Outcome measures
| Measure |
Mild Renal Impairment
n=6 Participants
eGFR 60 to 89 mL/min/1.73 m\^2
|
Moderate Renal Impairment
n=6 Participants
eGFR 30 to 59 mL/min/1.73 m\^2
|
Severe Renal Impairment
n=6 Participants
eGFR \<30 mL/min/1.73 m\^2, Not Requiring Dialysis
|
Healthy Volunteers
n=6 Participants
eGFR \>=90 mL/min/1.73 m\^2
|
|---|---|---|---|---|
|
Number of Patients Reporting Treatment-Emergent Adverse Events (TEAEs) [Safety]
|
0 participants
|
0 participants
|
2 participants
|
9 participants
|
Adverse Events
Group 1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 3
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Group 4
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group 1
n=6 participants at risk
Mild Renal Impairment eGFR 60 to 89 mL/min/1.73 m\^2
|
Group 2
n=6 participants at risk
Moderate Renal Impairment eGFR 30 to 59 mL/min/1.73 m\^2
|
Group 3
n=6 participants at risk
Severe Renal Impairment eGFR \<30 mL/min/1.73 m\^2, Not Requiring Dialysis
|
Group 4
n=6 participants at risk
Healthy Volunteers eGFR \>=90 mL/min/1.73 m\^2
|
|---|---|---|---|---|
|
General disorders
Injection site erythema
|
0.00%
0/6 • From the date of the signing of the consent form until follow-up visit on Day 8.
|
0.00%
0/6 • From the date of the signing of the consent form until follow-up visit on Day 8.
|
16.7%
1/6 • From the date of the signing of the consent form until follow-up visit on Day 8.
|
66.7%
4/6 • From the date of the signing of the consent form until follow-up visit on Day 8.
|
|
General disorders
Injection site pruritus
|
0.00%
0/6 • From the date of the signing of the consent form until follow-up visit on Day 8.
|
0.00%
0/6 • From the date of the signing of the consent form until follow-up visit on Day 8.
|
16.7%
1/6 • From the date of the signing of the consent form until follow-up visit on Day 8.
|
16.7%
1/6 • From the date of the signing of the consent form until follow-up visit on Day 8.
|
|
General disorders
Injection site induration
|
0.00%
0/6 • From the date of the signing of the consent form until follow-up visit on Day 8.
|
0.00%
0/6 • From the date of the signing of the consent form until follow-up visit on Day 8.
|
0.00%
0/6 • From the date of the signing of the consent form until follow-up visit on Day 8.
|
16.7%
1/6 • From the date of the signing of the consent form until follow-up visit on Day 8.
|
|
Investigations
Blood pressure decrease
|
0.00%
0/6 • From the date of the signing of the consent form until follow-up visit on Day 8.
|
0.00%
0/6 • From the date of the signing of the consent form until follow-up visit on Day 8.
|
0.00%
0/6 • From the date of the signing of the consent form until follow-up visit on Day 8.
|
16.7%
1/6 • From the date of the signing of the consent form until follow-up visit on Day 8.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • From the date of the signing of the consent form until follow-up visit on Day 8.
|
0.00%
0/6 • From the date of the signing of the consent form until follow-up visit on Day 8.
|
0.00%
0/6 • From the date of the signing of the consent form until follow-up visit on Day 8.
|
16.7%
1/6 • From the date of the signing of the consent form until follow-up visit on Day 8.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/6 • From the date of the signing of the consent form until follow-up visit on Day 8.
|
0.00%
0/6 • From the date of the signing of the consent form until follow-up visit on Day 8.
|
0.00%
0/6 • From the date of the signing of the consent form until follow-up visit on Day 8.
|
16.7%
1/6 • From the date of the signing of the consent form until follow-up visit on Day 8.
|
Additional Information
Executive Director Clinical Trials
Eloxx Pharmaceuticals
Phone: 1-781-577-5300
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place