Phase 1
Completed N=95
PK Study of PT003 and PT001 in Japanese Healthy Subjects
Source: ClinicalTrials.gov NCT02196714 ↗Enrolled (actual)
95
Serious AEs
0.0%
Results posted
Apr 2017
Primary outcomePrimary: Cmax — 15.23; 9.09; 16.85; 7.26 pg/mL
Summary
A Randomized, Double-Blind, Single-Dose, Four-Period, Four-Treatment, Cross-Over, Single-Center, Phase I, Crossover Study in Healthy Japanese Adult Subjects to Evaluate the Safety and Pharmacokinetics of Two Doses of PT003 and Two Doses of PT001.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cmax |
10.74; 11.99 | — |
| PRIMARY AUC 0-12 |
44.15; 42.54 | — |
| PRIMARY AUC 0-t |
45.96; 42.39 | — |
| PRIMARY AUC 0-∞ |
61.88; 61.43 | — |
| PRIMARY Tmax |
0.10; 0.10 | — |
| PRIMARY T 1/2 |
5.45; 5.25 | — |
| PRIMARY CL/F |
168.95; 161.55 | — |
| PRIMARY Vd/F |
1187.75; 1054.16 | — |
| PRIMARY Lambda z |
0.1412; 0.1470 | — |
| SECONDARY Change in Mean Hematology Parameters (±SD) From Pre-dose to 12 Hours Post-dose |
-0.391; -0.419; -0.433 | — |
| SECONDARY Change in Mean Chemistry Parameters (±SD) From Pre-dose to 12 Hours Post-dose |
-14.169; -11.949; -11.669 | — |
| SECONDARY Change in Mean Glucose and Potassium Results (±SD) From Pre-dose to 12 Hours Post-dose |
-0.03; -0.08; -0.01; 0.05; -0.01; -0.06 | — |
| SECONDARY Change in Heart Rate From Pre-dose to 12 Hours Post Dose |
11.3; 9.3; 4.5 | — |
| SECONDARY Change in PR Interval From Pre-dose to 12 Hours Post Dose |
-10.7; -8.5; -7.4 | — |
| SECONDARY Change in QRS Axis From Pre-dose to 12 Hours Post Dose |
-0.5; 4.1; 0.0 | — |
| SECONDARY Change in QRS Duration From Pre-dose to 12 Hours Post Dose |
-3.9; -1.1; -4.0 | — |
| SECONDARY Change in QT Interval From Pre-dose to 12 Hours Post Dose |
-28.5; -24.8; -20.5 | — |
| SECONDARY Change in QTc Bazett Interval From Pre-dose to 12 Hours Post Dose |
7.2; 4.4; -5.8 | — |
| SECONDARY Change in QTc Fridericia's Interval From Pre-dose to 12 Hours Post Dose |
-4.8; -5.4; -10.8 | — |
Eligibility Criteria
Inclusion Criteria
Informed Consent Form (ICF) prior to any study related procedures
- Male and female first generation Japanese subjects 18 to 45 years, inclusive
- Good general health
- Medically acceptable contraception for women of child-bearing potential and males with female partners of childbearing potential
- Clinical labs within normal ranges or determined to be not clinically significant by the Investigator
Exclusion Criteria
- Pregnancy, nursing female subjects, or subjects trying to conceive
- Clinically significant neurologic, cardiovascular, hepatic, renal, endocrinologic, pulmonary, hematological, psychiatric, or other medical illness that would interfere with participation in this study
- History of ECG abnormalities
- Cancer not in complete remission for at least 5 years
- Clinically significant, symptomatic prostatic hypertrophy
- Male subjects with a trans-urethral resection of the prostate or full resection of the prostate within 6 months prior to Screening
- Clinically significant bladder neck obstruction or urinary retention
- Inadequately treated glaucoma
- History of an allergic reaction or hypersensitivity to any drug or to any component of the formulations used in this study
- Subjects with pre-existing anemia and/or iron deficiency
Data sourced from ClinicalTrials.gov (NCT02196714). 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.