Phase 1
N=14
A Single-Dose Trial to Examine the Within Subject Variability of Clexane® in Healthy Adults Under Fasting Conditions
Clexane is Administered to Healthy Volunteers
Bottom Line
View on ClinicalTrials.gov: NCT02081950 ↗Enrolled (actual)
14
Serious AEs
0.0%
Results posted
Sep 2020
Primary outcome: Primary: Anti-FXa Cmax — 0.999; 0.926 IU/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Enoxaparin sodium (Biological)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Chemi S.p.A.
- Primary completion
- Mar 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Anti-FXa Cmax |
0.999; 0.926 | — |
| PRIMARY Anti-FXa AUC0-t |
9.511; 9.479 | — |
| PRIMARY Anti-FXa AUC0-inf |
9.911; 9.949 | — |
| PRIMARY Anti-FIIa Cmax |
0.112; 0.107 | — |
| PRIMARY Anti-FIIA AUC0-t |
0.692; 0.696 | — |
| PRIMARY Anti-FIIA AUC0-inf |
1.107; 1.127 | — |
| SECONDARY Anti-FXa Tmax |
3.50; 4.36 | — |
| SECONDARY Anti-FXa Lambda Zeta |
0.16; 0.14 | — |
| SECONDARY Anti-FXa t1/2 |
4.87; 5.19 | — |
| SECONDARY Anti-FXa Cmin |
0.000; 0.004 | — |
| SECONDARY Anti-FXa Tmin |
2.57; 0.00 | — |
| SECONDARY Anti-FIIa Tmax |
3.61; 4.00 | — |
| SECONDARY Anti-FIIa Lambda Zeta |
0.19; 0.17 | — |
| SECONDARY Anti-FIIa t1/2 |
4.45; 4.86 | — |
| SECONDARY Anti-FIIa Cmin |
0.000; 0.000 | — |
| SECONDARY Anti-FIIa Tmin |
0.00; 0.00 | — |
| SECONDARY Thrombin/FIIa Generation AUC0-t |
4034.262; 4050.840 | — |
| SECONDARY Thrombin/FIIa Generation Cmin |
17.407; 16.971 | — |
| SECONDARY Thrombin/FIIa Generation Tmin |
3.500; 3.250 | — |
| SECONDARY TFPI Cmax |
2.349; 2.344 | — |
| SECONDARY TFPI Tmax |
2.79; 2.54 | — |
| SECONDARY TFPI Lambda Zeta |
0.019; 0.014 | — |
| SECONDARY TFPI T1/2 |
37.17; 57.49 | — |
| SECONDARY TFPI AUC0-t |
55.208; 53.937 | — |
| SECONDARY TFPI AUC0-inf |
123.777; 162.976 | — |
| SECONDARY TFPI Tmin |
18.860; 17.430 | — |
| SECONDARY TFPI Cmin |
1.253; 1.227 | — |
| SECONDARY Anti-FXa/Anti-FIIa Cmax |
9.095; 9.020 | — |
| SECONDARY Anti-FXa/Anti-FIIa AUC0-t |
15.137; 16.927 | — |
| SECONDARY Anti-FXa/Anti-FIIa AUC0-inf |
10.143; 8.941 | — |
| SECONDARY Anti-FXa/Anti-FIIa Tmax |
1.02; 1.11 | — |
| SECONDARY Anti-FXa/Anti-FIIa Lambda Zeta |
1.09; 1.05 | — |
| SECONDARY Anti-FXa/Anti-FIIa t1/2 |
1.37; 1.30 | — |
| SECONDARY Number of Patients With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs and Severity of TEAEs |
4; 2; 0; 0; 0; 0 | — |
Summary
Primary: To examine the within subject variability of Clexane (80 mg) in healthy male and female volunteers administered subcutaneously (s.c.) as a single dose, in two periods, under fasting conditions.
Secondary: To monitor safety during the Treatment Periods.
Eligibility Criteria
Inclusion Criteria
- Healthy male or female volunteer between 18 and 55 years of age.
- Female subject of child bearing potential with a negative pregnancy test at the Screening Visit and willing to use 2 effective methods of contraception from Day 1 until 3 months afterwards.
- Subject with no clinically significant abnormal serum biochemistry, haematology, coagulation factors and urine examination values within 14 days of the first dose.
Exclusion Criteria
- Female subject with weight 5 cups of coffee or equivalent per day).
- Subject who was a smoker (cigarettes and tobacco-related products), or ex-smoker who had smoked in the 3 months preceding the study. Subjects were tested for urinary cotinine at screening.
- Subjects who could not tolerate venepuncture.
- Inability to communicate well with the Investigator (i.e., language problem, poor mental development or impaired cerebral function).
- Participation in a New Chemical Entity clinical study within the previous 4 months or a marketed drug clinical study within the previous 3 months.
Data sourced from ClinicalTrials.gov (NCT02081950). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.