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A first-in-human single-dose escalation study of the safety, pharmacokinetics and pharmacodynamics of the test drug including brain Serotonin Receptor Transporter (SERT) occupancy by Positron Emission Tomography (PET).

A first-in-human single-dose escalation study of the safety, pharmacokinetics and pharmacodynamics of the test drug including brain Serotonin Receptor Transporter (SERT) occupancy by Positron Emission Tomography (PET). - new drug SRD/PET study.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON34991
Enrollment
38
Registered
2009-12-28
Start date
2010-02-01
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

pijn aan beschadigde organen visceral pain

Interventions

Active substance: LY2878735 Activity: Combined serotonin and noradrenaline transporter inhibitor Indication: Visceral pain syndromes Strength: 5 mg, 20 mg and 70 mg Dosage form: capsules Treatments

Sponsors

Eli Lilly
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Healthy male, age between 18 and 65 years, BMI between 19 and 32.5 kg/m2, non-smoker or moderate smoker, at screening state of health must satisfy the entry requirements. ;Only part B: Non-exposure to any radiation for diagnostic reasons during work or during participation in a medical trial in the past year, non claustrophobic.

Exclusion criteria

Exclusion criteria: D5a: Suffering from: hepatitis B, cancer or HIV/AIDS. In case of participation in another drug study within 60 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

MeasureTime frame
Pharmacodynamics: plasma DHPG and NE concentrations, NE/5-HT uptake inhibition, occupancy of transporter sites Pharmacokinetics: plasma concentrations, pharmacokinetic parameters Safety: adverse events, vital signs, ECG-parameters, laboratory parameters, physical examination

Secondary

MeasureTime frame
n.a.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)