Phase 1
Completed N=78
Study to Determine the Safety, Tolerability, and Pharmacokinetic (PK) Profile of EGT0001474 in Healthy Volunteers
Safety and Tolerability of EGT0001474 in Healthy Volunteers
Source: ClinicalTrials.gov NCT00854113 ↗
Enrolled (actual)
78
Serious AEs
0.0%
Results posted
Aug 2011
Primary outcomePrimary: Cmax — 12.7; 28; 90.7; 194 ng/ml
Summary
This study evaluated the safety, tolerability and pharmacokinetics of single or multiple doses of EGT0001474.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cmax |
12.7; 28; 90.7; 194; 537; 1183 | — |
| PRIMARY Tmax |
4; 2.01; 2; 1.51; 1.5; 1.5 | — |
| PRIMARY AUC 0-t |
67.4; 126; 388; 1200; 2564; 6412 | — |
| PRIMARY t1/2 |
3.66; 4.19; 5.81; 9.71; 9.27; 11.4 | — |
| PRIMARY AUC 0 -24 |
85.6; 145; 392; 1121; 2383; 5828 | — |
| PRIMARY Terminal Rate Constant. |
0.193; 0.177; 0.126; 0.0799; 0.0765; 0.0637 | — |
| PRIMARY CL/F |
28.9; 35.3; 25.9; 21.2; 30.1; 23.1 | — |
| PRIMARY VZ/F |
154; 222; 208; 287; 398; 385 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female volunteers between the ages of 18 and 55 years inclusive.
- In good health.
- Female subjects must be surgically sterilized or postmenopausal.
- Body mass index (BMI) between 18 kg/m2 and 30 kg/m2 inclusive.
- Non-smoker.
- Negative drug and alcohol screens.
Exclusion Criteria
- Abnormal ECG
- Sitting blood pressure above 140/90 mmHg on 2 evaluations at least 10 minutes apart at screening
- Treatment with an investigational drug within 30 days or 7 half-lives, whichever is longer.
- Previous treatment with EGT0001474.
- History of drug abuse.
- Febrile illness within 5 days prior to the first dose of study medication.
Data sourced from ClinicalTrials.gov (NCT00854113). 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. Informational only — not medical advice.