A Randomized, Double-blind, Placebo-controlled, Single Center Study of the Safety, Tolerability, Pharmacokinetics (Including Food Effects) of Single or Multiple Doses of ABT-639 in Healthy Adults and Elderly Subjects

A Randomized, Double-blind, Placebo-controlled, Single Center Study of the Safety, Tolerability, Pharmacokinetics (Including Food Effects) of Single or Multiple Doses of ABT-639 in Healthy Adults and Elderly Subjects - ABT-639 SAD/MAD/FE/elderly study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON34223

Enrollment

124

Registered

2010-04-06

Start date

2010-05-31

Completion date

Unknown

Last updated

2024-05-06

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

Conditions

Zenuwpijn armen en benen Nerve Pain

Interventions

Study Medication Active substance: ABT-639 Activity : pain Indication : calcium channel blocker Strength : 1, 10 and 100 mg Dosage form: capsule Part I (SAD) Group 1: a single oral dose of 30 mg ABT

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 18 - 55 years (Parts I, II and III), at least 65 years or older (Part IV), BMI 18 - 30kg/m2, no smoking for at least 6 months, good general health.

Exclusion criteria

Exclusion criteria: Suffering from: hepatitis B, cancer or HIV/AIDS. In case of participation in another drug study within 90 days before the start of this study or being a blood donor within 90 days from the start of the study. In case of donating more than 1.5 liters of blood in the 10 months prior the start of this study.

Design outcomes

Primary

Measure	Time frame
Pharmacokinetics: plasma and urine ABT-639 concentrations, pharmacokinetic parameters Safety : adverse events, vital signs, ECG-parameters, laboratory parameters, physical examination,	—

Secondary

Measure	Time frame
n.a.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)