NCT00888693

Brief Summary

Evaluate the safety, tolerability and pharmacokinetics of ABT-288 in order to determine the maximum tolerated dose of ABT-288 in stable schizophrenic volunteers receiving treatment with an atypical antipsychotic.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
81

participants targeted

Target at P75+ for phase_1 schizophrenia

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2008

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 27, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 28, 2009

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Last Updated

November 21, 2017

Status Verified

October 1, 2010

Enrollment Period

1.1 years

First QC Date

April 27, 2009

Last Update Submit

November 17, 2017

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (2)

  • Physical Exams, Brief Neurological Exams, Vitals, Orthostatic Vitals, ECG, Laboratory tests,

    Days -1 to 21

  • Pharmacokinetics; optional CSF for arms 7, 8 & 9

    Days -1 to 21

Secondary Outcomes (4)

  • Extrapyramidal Symptom Rating Scale

    Day -1, Day 14

  • Columbia Suicide Severity Rating Scale

    Screening, Day 15

  • Pharmacodynamics: CANTAB & PANSS

    Screening, Day -1, Day 14

  • Pharmacodynamics: Pittsburgh Sleep Quality Index-Modified

    Day -1, Day 15

Study Arms (9)

1

EXPERIMENTAL

ABT-288 vs placebo capsules administered orally once daily for 14 days

Drug: ABT-288Drug: Placebo

2

EXPERIMENTAL

ABT-288 vs placebo capsules administered orally once daily for 14 days

Drug: ABT-288Drug: Placebo

3

EXPERIMENTAL

ABT-288 vs placebo capsules administered orally once daily for 14 days

Drug: ABT-288Drug: Placebo

4

EXPERIMENTAL

ABT288 vs placebo administered orally once daily for 14 days

Drug: ABT-288Drug: Placebo

5

EXPERIMENTAL

ABT-288 vs placebo administered orally once daily for 14 days

Drug: ABT-288Drug: Placebo

6

EXPERIMENTAL

ABT-288 vs placebo administered orally once daily for 14 days

Drug: ABT-288Drug: Placebo

7

EXPERIMENTAL

ABT-288 vs placebo administered orally once daily for 14 days

Drug: ABT-288Drug: Placebo

8

EXPERIMENTAL

ABT-288 vs placebo administered orally once daily for 14 days

Drug: ABT-288Drug: Placebo

9

EXPERIMENTAL

ABT-288 vs placebo administered orally once daily for 14 days

Drug: ABT-288Drug: Placebo

Interventions

ABT-288DRUG

See Arm Description for details.

123456789
PlaceboDRUG

See Arm Description for details.

123456789

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Subject has signed informed consent;
  • Current DSM-IV-TR diagnosis of schizophrenia;
  • Clinically stable on the same single second-generation antipsychotic for the past 8 weeks;
  • Meets study-specific PANSS criteria;
  • Willing and able to cooperate with cognitive testing
  • Females are not pregnant, not breast-feeding;
  • Females are post-menopausal or surgically sterile or practicing birth control;
  • Males are surgically sterile or agree to be sexually inactive or use barrier method of birth control

You may not qualify if:

  • Subject has a substance dependence disorder that has not been in sustained remission for at least 1 year;
  • Diagnosis of schizoaffective disorder;
  • Bipolar disorder, manic episode, dementia, OCD, or drug-induced psychosis or current major depressive disorder;
  • Diagnoses with mental retardation; acute psychosis hospitalization within past 6 months;
  • Current clozapine treatment; suicidal ideation or behavior;
  • BMI of 39 or greater; current homicidal or violent ideation;
  • Medical or CNS condition other than schizophrenia that could affect cognitive performance or testing; relevant drug sensitivity or allergy; positive urine screen for alcohol or drugs of abuse;
  • Positive hepatitis or HIV test result;
  • Recent clinically significant illness/infection or surgery;
  • Recent blood product transfusion, donation or loss of 5 mL/kg of blood;
  • Visual, hearing or communication disability

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Othman AA, Haig G, Florian H, Locke C, Gertsik L, Dutta S. The H3 antagonist ABT-288 is tolerated at significantly higher exposures in subjects with schizophrenia than in healthy volunteers. Br J Clin Pharmacol. 2014 Jun;77(6):965-74. doi: 10.1111/bcp.12281.

    PMID: 24215171BACKGROUND

MeSH Terms

Conditions

Schizophrenia

Interventions

2-(4'-(5-methylhexahydropyrrolo(3,4-b)pyrrol-1-yl)biphenyl-4-yl)-2H-pyridazin-3-one

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 27, 2009

First Posted

April 28, 2009

Study Start

November 1, 2008

Primary Completion

December 1, 2009

Last Updated

November 21, 2017

Record last verified: 2010-10