Phase 1
Completed N=30
Phase I, Escalating, Multiple-Dose, ST-246 Safety, Tolerability and Pharmacokinetics 21-Day Trial in Healthy Volunteers
Healthy
Source: ClinicalTrials.gov NCT00431951 ↗
Enrolled (actual)
30
Serious AEs
0.0%
Results posted
May 2010
Primary outcomePrimary: Number of Study Participants Who Tolerated ST-246 (250, 400 or 800mg) as Determined by Changes in Safety Parameters, According to the Division of Acquired Immunodeficiency Syndrome (DAIDS) Adverse Events (AE) Grading Table — 8; 8; 7; 6 Participants
Summary
The purpose of this study was to assess the safety, tolerability, and pharmacokinetics of a single, daily, oral dose of ST-246 (either 250, 400 or 800mg) administered for 21 days to 30 healthy, fed volunteers.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Study Participants Who Tolerated ST-246 (250, 400 or 800mg) as Determined by Changes in Safety Parameters, According to the Division of Acquired Immunodeficiency Syndrome (DAIDS) Adverse Events (AE) Grading Table |
8; 8; 7; 6 | — |
| SECONDARY Evaluation of Pharmacokinetic Parameters to Assess Interventions: Cmax |
1101; 1457; 2437; 0 | — |
| SECONDARY Evaluation of Pharmacokinetic Parameters to Assess Interventions: Tmax |
2.9; 2.7; 3.2; 0 | — |
| SECONDARY Evaluation of Pharmacokinetic Parameters to Assess Interventions: t½ |
18.8; 19.9; 20.7; 0 | — |
| SECONDARY Evaluation of Pharmacokinetic Parameters to Assess Interventions: AUCtau |
10083; 16182; 22684; 0 | — |
| SECONDARY Evaluation of Pharmacokinetic Parameters to Assess Interventions: Ae(0-24) |
0.049; 0.108; 0.213; 0 | — |
Eligibility Criteria
Subject Inclusion Criteria:
- Healthy volunteers
- Ability to Consent
- Not taking any other medication
- Adequate venous access
- Using adequate birth control
Subject Exclusion Criteria:
- Inability to swallow study medication.
- Pregnant or breastfeeding
- Received experimental drug within 30 days of study entry or will participate in any experimental study during the study period.
- Current drug abuse, alcohol abuse, or homelessness.
- Taking concomitant medication
- Lactose Intolerance
- Medical condition; e.g., asthma, diabetes, thyroid disease, angioedema, BMI >35 or <18, hypertension, bleeding disorder, malignancy, seizure, neutropenia, Hepatitis B or C, HIV or AIDS.
- Any condition, occupational reason or other responsibility that, in the judgment of the Investigator, would jeopardize the safety or rights of a volunteer, or render the subject unable to comply with the protocol
Data sourced from ClinicalTrials.gov (NCT00431951). 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.