A Phase 1, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Doses of ISIS 325568 Administered to Healthy Volunteers

A Phase 1, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Doses of ISIS 325568 Administered to Healthy Volunteers - Antisense glucagon receptor in healthy volunteers

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON31095

Enrollment

Registered

2007-08-14

Start date

2007-08-20

Completion date

Unknown

Last updated

2024-05-13

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

Conditions

diabetes mellitus disorder with hyperglycemia

Interventions

ISIS 325568 or placebo

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. healthy subjects of either gender aged between 18-65 years 2. Females must be non-pregnant and non-lactating, and either surgically sterile (hysterectomy, oophrectomy, or tubal ligation) or postmenopausal. Males must be surgically sterile, abstinent or if engaged in sexual relations of child-bearing potential, subject or partner must be using an acceptable contraceptive method during the trial and for 9 weeks after the last dose of study drug. 3. Give written informed consent to participate in study and availability for all study requirements 4. Fasting plasma glucose

Exclusion criteria

Exclusion criteria: 1. Clinically significant abnormalities in medical history or physical examination 2. Abnormalities on laboratory examination (ALT > ULN, AST > ULN, bilirubin > ULN, creatinine > ULN, urine protein positive by urine dipstick, platelets 1 year) 8. Any other concurrent condition which, in the opinion of the Investigator, would preclude participation in this study or interfere with compliance 9. History of alcohol or drug abuse 10. Undergoing or have undergone treatment with another investigational drug, biologic agent or device within 90 days prior to Screening. 11. Blood donation within three months of screening

Design outcomes

Primary

Measure	Time frame
Tolerability of ISIS 325568 PK of ISIS 325568 Effects of ISIS 325568 (hepatic glucose production)	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)