Phase 1
Completed N=28
Trial for Studying Pharmacokinetic Effects of Ketoconazole on CG100649
Healthy
Source: ClinicalTrials.gov NCT01154764 ↗
Enrolled (actual)
28
Serious AEs
0.0%
Results posted
Jan 2024
Primary outcomePrimary: Cmax — 11.0; 107 ng/mL
Summary
This is a Phase I, open-labeled, randomization and 2x2 Cross trial to compare the pharmacokinetic effects between ketoconazole and CG100649 for healthy male volunteers.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cmax |
11.0; 107 | — |
| PRIMARY AUClast |
2685.8; 2074 | — |
Eligibility Criteria
Inclusion Criteria
- Age 19-55 years old and weight 50kg above with within 20% of ideal body weight
- No significant chronic/congenital disease
- Normal results for lab test
- Ability of informed consent
Exclusion Criteria
- History or presence of liver, kidney, or nervous system disease, respiratory disorders, endocrinological disorders, hemato-oncologic, cardiovascular or psychiatric or cognitive disorders.
- History of gastrointestinal disorders (bleeding, ulceration, hemorrhoids, piles) or disorders of absorption, distribution, metabolism, excretion.
- History of known hypersensitivity to drugs including CG100649.
- After taking a rest in sitting position for 3 minutes, subjects who have low blood pressure (Systolic BP ≤ 90 mmHg or Diastolic BP ≤ 50 mmHg) or high blood pressure (Systolic BP ≥ 150 mmHg or Diastolic BP ≥ 100 mmHg).
Data sourced from ClinicalTrials.gov (NCT01154764). 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.