Safety, tolerability, pharmacokinetic and pharmacodynamic effects of single and multiple escalating doses of ODM-108: a single centre study in healthy male volunteers.

Safety, tolerability, pharmacokinetic and pharmacodynamic effects of single and multiple escalating doses of ODM-108: a single centre study in healthy male volunteers. - ODM-108 SAD and MAD study.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON42514

Enrollment

206

Registered

2015-04-07

Start date

2015-04-14

Completion date

Unknown

Last updated

2024-04-23

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

Conditions

Neuropathische pijn. Nerve damage pain.

Interventions

n.a.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Healthy male volunteers 18 - 55 years, inclusive BMI 18 - 30 kilograms/meter2 Weight 55 - 95 kilograms, inclusive

Exclusion criteria

Exclusion criteria: Suffering from hepatitis B, hepatitis C, 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 60 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
The primary objective of Part I is to evaluate the safety and tolerability of single escalating doses of ODM-108 compared to placebo. The primary objective of Part II is to evaluate the safety and tolerability of repeated, escalating doses of ODM-108 compared to placebo. The primary objective of optional Part III is to evaluate the effect of ODM-108 on CYP3A4 activity.	—

Secondary

Measure	Time frame
To determine the dose-effect of ODM-108 on the intensity of spontaneous pain, on the area of secondary hyperalgesia and the area of flare in response to intradermal capsaicin during Parts I and II. To determine the dose-effect of ODM-108 on the intensity of spontaneous pain, on the area of secondary hyperalgesia, and the area of flare in response to topical mustard oil during Part II. * To evaluate the pharmacokinetic profile of ODM-108 and any putative metabolites. To evaluate the effect of a standard breakfast on ODM-108 with respect to the pharmacokinetic profile of ODM-108 and metabolites during Part II. To evaluate the effect of ODM-108 on the subjective assessment of sedation in Parts I and II, and on a concise battery of psychomotor tests and body sway during Part II. To evaluate the effect of ODM-108 on CYP3A4 hepatic enzyme induction, as assessed by the biomarkers 6-hydroxycortisol/total cortisol and 4- hydroxycholesterol during Part II of the study	—

Measure

Time frame

To determine the dose-effect of ODM-108 on the intensity of spontaneous pain, on the area of secondary hyperalgesia and the area of flare in response to intradermal capsaicin during Parts I and II. To determine the dose-effect of ODM-108 on the intensity of spontaneous pain, on the area of secondary hyperalgesia, and the area of flare in response to topical mustard oil during Part II. * To evaluate the pharmacokinetic profile of ODM-108 and any putative metabolites. To evaluate the effect of a standard breakfast on ODM-108 with respect to the pharmacokinetic profile of ODM-108 and metabolites during Part II. To evaluate the effect of ODM-108 on the subjective assessment of sedation in Parts I and II, and on a concise battery of psychomotor tests and body sway during Part II. To evaluate the effect of ODM-108 on CYP3A4 hepatic enzyme induction, as assessed by the biomarkers 6*-hydroxycortisol/total cortisol and 4*- hydroxycholesterol during Part II of the study

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)