abdominal pain and heartburn
Conditions
Interventions
Every subject is only allowed to participate after randomization to one of the
cohorts. Per treatment subjects will receive the study drug for 14 consecutive
days.
Part 1:
Treatment A 50 mg JNJ-2607
Sponsors
Janssen-Cilag
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Female subjects must not be of childbearing potential, ie must be surgically sterile (> 6 months) or post-menopausal (no menses for > 2 years). Subjects must have supine blood pressure (after resting for 5 min) between the range of 95 - 139 mm Hg systolic (inclusive), and 50 - 89 mm Hg diastolic (inclusive). Subjects must be in good general health prior to study participation with no clinically relevant abnormalities as assessed by the investigator and determined by: medical history, physical examination, blood chemistry, complete blood count (CBC), UA, and ECG. Male subjects must consent to utilize a medically acceptable method of contraception throughout the entire study period and for 3 months after the study is completed. Subjects must be Helicobacter pylori negative at screening.
Exclusion criteria
Exclusion criteria: Subjects with evidence of clinically significant hepatic, reproductive, gastrointestinal, renal, hematologic, pulmonary, neurologic, respiratory, endocrine/metabolic, or cardiovascular system abnormalities, psychiatric disorders, oncologic conditions or acute or chronic infection. Subjects with past or current gastric or duodenal ulceration. Subjects with history of lactose intolerance. Subjects who have a history of having a first degree relative die from cardiac causes prior to the age of 40 years. Subjects with significant history of heartburn or other symptoms of gastroesophageal reflux disease (GERD) or subjects who have used prescription, or non-prescription medications, for symptoms of heartburn or symptoms of GERD within 3 months prior to screening. Subjects who have taken JNJ-26070109 previously in a clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability, pharmocokinetic and pharmacodynamic blood and urine tests, adverse events, safety laboratory parameters, vital signs, heart rate, ECG, alcohol breath test and continuously hearth rhythm (telemetry) . For Part 2 also a Helicobacter pylori breath test and intra-gastric pH measurements will be assessed for a period of 24 hours, on Day -1, Day 1, Day 7 and Day 14. and finished 24 hours after dosing. | — |
Secondary
| Measure | Time frame |
|---|---|
| Not applicable. | — |
Countries
Netherlands
Outcome results
None listed