A Randomized, Double-Blind, Placebo-Controlled Study in Healthy Male Subjects to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Oral Doses of JNJ-26070109

A Randomized, Double-Blind, Placebo-Controlled Study in Healthy Male Subjects to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Oral Doses of JNJ-26070109 - N/A

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON30044

Enrollment

Registered

2006-06-01

Start date

2006-06-08

Completion date

Unknown

Last updated

2024-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

abdominal pain and heartburn

Interventions

Every subject is only allowed to participate after randomisation to one of the cohorts. Cohort 1: single oral dose of 5 mg of JNJ-26070109 suspension or placebo Cohort 2: single oral dose of 15 mg o

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Healthy males without evidence of gastro-intestinal disorders

Exclusion criteria

Exclusion criteria: Subjects with evidence of clinically significant reproductive, gastrointestinal, renal, hematologic, pulmonary, neurologic, respiratory, endocrine/metabolic, or cardiovascular system abnormalities, psychiatric disorders, oncologic conditions or acute or chronic infection. Subjects with a history of any hepatic disorder or history of hepatitis. Subjects with known elevations of LFTs, alkaline phosphatase, gamma-GT, or bilirubin in the past. Negative Helicobacter pylori serum IgG antibody

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 cohort 8 also intra-gastric pH measurements will be assessed for a period of 48 hours, starting on Day -1 and finished 24 hours after dosing.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)