CompletedNCT02530580Updated Jul 27, 2016

Effects of GABA Modulator AZD7325 on Cutaneous Sensation

A Phase 1 interventional study of 20 mg AZD7325 and Placebo in Healthy, sponsored by University College, London. Completed at 1 site in United Kingdom. Open to male participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-07-27.

Sponsored by University College, London · Phase 1, Interventional, and Basic science

Phase: Phase 1
Study type: Interventional
Enrollment: 12
Allocation: Randomized
Ages: 18 Years to 55 Years
Sex: Male

Study summary

GABA (gamma-aminobutyric acid) is the main inhibitory neurotransmitter in the human brain. For years, drugs that enhance its effects (e.g., benzodiazepines such as diazepam/Valium) have been used to treat various diseases such as epilepsy, insomnia, anxiety or movement disorders. However, the use of these medications is often compromised because of their side effects, such as sleepiness, memory problems, and addiction.

Therefore, effort has been made to develop drugs that act more selectively in the brain to exert the positive therapeutic effects and are devoid of the unwanted side effects. AZD7325 is one of these drugs. It has been tested in more than 700 people and so far proved to be generally well tolerated. Positron emission tomography (PET) study in humans demonstrated that AZD7325 binds to GABA A receptors in the brain after a single dose. Early clinical studies have shown that it has less sedative and cognitive adverse events as compared with a benzodiazepine lorazepam.

The investigators now wish to evaluate if effects of AZD7325 can be objectively measured in healthy volunteers and to establish which of the drug's outcomes could be utilised for further studies in patients with neurological diseases.

The investigators are especially interested in the effects of AZD7325 on manual dexterity and skin sensation of the hand. This can be assessed by a number of simple non-invasive tests of object manipulation and detection of different sensory stimuli such as touch, vibration, or temperature. Recent studies show that healthy individuals who performed better in similar tasks had more GABA in relevant areas of their brain. If performance in these tasks in healthy volunteers can be improved by enhancing GABA effects in the brain with AZD7325, this would create the grounds for the use of this medication to treat symptoms of certain neurological disorders in which motor control and sensation of the hand is impaired (e.g., polyneuropathy).

Conditions studied

Healthy

Keywords

GABA modulator
AZD7325
Object manipulation
Cutaneous sensation
Manual dexterity

In context

Lead sponsor

University College, London is the lead sponsor of 632 studies on the registry; 145 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 55 Years
Sexes eligible: Male
Accepts healthy volunteers: Yes

Inclusion criteria

Male adults aged 18 to 55 years (extremes are included)
A body weight resulting in a body mass index (BMI) of 18-30 kg/m2 (extremes included) using the formula BMI = body-weight [in kg] / body-height [in m]2
Able and willing to sign the Informed Consent Form prior to screening evaluations.
History of good physical and mental health as determined by history taking and laboratory examinations, ECG, blood pressure and heart rate recordings as judged by the investigator
Willing not to consume alcohol or to smoke or chew tobacco on days of assessments
Subjects must be willing to avoid unprotected vaginal intercourse with women of child bearing potential (see above under 3.5) or donating sperm for the duration of the study and a further 1 week after drug administration.

Exclusion criteria

Exclusion Criteria:

History of allergy/idiosyncrasy to AZD7325 or chemically related compounds or excipients which may be employed in the study or to any other drug used in the past
Subject has taken systemically (po, iv) any potent or moderate CYP3A4 or CYP2C9 inhibitor, 1 month prior to screening (topical or inhaled are permitted) such as: aprepitant, barbiturates, carbamazepine, clarithromycin, erythromycin, cyclosporine, diltiazem, efavirenz, fluconazole, HIV protease inhibitors, glucocorticoids, itraconazole (oral/IV), ketoconazole, nefazodone, nevirapine, phenytoin, pioglitazone, primidone, rifabutin, rifampicin, telithromycin, St. John's wort, verapamil
Use of any prescription drug judged by the investigator as potentially interfering with this trial within two weeks prior to the first dosing, except for topical medication without systemic exposure
Clinically relevant history or presence of any medical disorder, potentially interfering with this trial
Clinically relevant abnormal laboratory, ECG, HR or BP at screening as judged by the investigator
History of or current abuse of drugs (including prescription medication) or alcohol or solvents
Smoking in excess of 5 cigarettes per day or the equivalent within 28 days prior to the screening visit
Smoking or chewing of tobacco or consume of alcohol, 24 hours before and on the days of assessment
Subject is family member or in the employment line management of study personnel
Subject has abnormal screening laboratory values
Subject's partner is planning pregnancy within 3 months of last dosing
Participation in an IMP intervention trial within last month or more than four in the previous 12 months
Abnormal responses in the object manipulation task and psychophysical measures, SDMT, VAS outside 95% confidence interval of normal at screening visit
Subjects with a history of epilepsy, seizures or episodes of unexplained and unprovoked loss of consciousness

Study design

Phase: Phase 1
Primary purpose: Basic science
Allocation: Randomized
Intervention model: Crossover assignment
Masking: Double (Participant, Investigator)
Enrollment: 12 participants (actual)

Study arms

Experimental
20 mg AZD7325
10 mg AZD7325 in orange capsule, Size 0, 2 capsules as a single oral dose
Drug: 20 mg AZD7325 · Drug: Placebo
Placebo comparator
Placebo
10 mg Microcrystalline cellulose in orange capsule, Size 0, 2 capsules as a single oral dose
Drug: 20 mg AZD7325 · Drug: Placebo

Interventions

Drug20 mg AZD7325
A single 20 mg oral dose of AZD7325
DrugPlacebo
A single oral dose

What researchers measure

Primary outcomes

Change in peak grip force in an object manipulation task
Time frame: from baseline at 1, 2, and 3 hours after the study medication

Secondary outcomes

Changes in parameters of object manipulation in a object manipulation task (grip force rate)
Parameters: grip force rate
Time frame: from baseline at 1, 2, and 3 hours after the study medication
Changes in parameters of object manipulation in a object manipulation task (load force rate)
Parameters: load force rate
Time frame: from baseline at 1, 2, and 3 hours after the study medication
Changes in parameters of object manipulation in a object manipulation task (static load force)
Parameters: static load force
Time frame: from baseline at 1, 2, and 3 hours after the study medication
Changes in parameters of object manipulation in a object manipulation task (static grip force)
Parameters: static grip force
Time frame: from baseline at 1, 2, and 3 hours after the study medication
Changes in parameters of object manipulation in a object manipulation task (9-hole pegboard test)
Parameters: 9-hole pegboard test
Time frame: from baseline at 1, 2, and 3 hours after the study medication
Changes in performance in the psychophysical tests of cutaneous sensation ("bumps" test)
Parameters: "bumps" test
Time frame: from baseline at 1, 2, and 3 hours after the study medication
Changes in performance in the psychophysical tests of cutaneous sensation (grating orientation task)
Parameters: grating orientation task
Time frame: from baseline at 1, 2, and 3 hours after the study medication
Changes in performance in the psychophysical tests of cutaneous sensation (vibrotactile sensitivity)
Parameters: vibrotactile sensitivity
Time frame: from baseline at 1, 2, and 3 hours after the study medication
Changes in performance in the psychophysical tests of cutaneous sensation (thermal sensitivity)
Parameters: thermal sensitivity
Time frame: from baseline at 1, 2, and 3 hours after the study medication
Change in the rating on a 0-100 mm Visual Analogue Scale (VAS) of degree of sedation
Time frame: from baseline at 1, 2, and 3 hours after the study medication
Change in the score of Symbol Digit Modalities Test (SDMT)
Time frame: from baseline at 1, 2, and 3 hours after the study medication
Safety and tolerability of a single dose of AZD7325 by assessment of adverse events, vital signs, physical examination, ECG, and laboratory variables
Composite outcome measure
Time frame: 3 times during the trial period, an expected average of 4 weeks (before each dose and 48-96 hours after the last dose of study medication). Adverse events also at follow-up telephone call within a week after the last dose of study medication

Study locations

1 site

National Hospital for Neurology and Neurosurgery
London, WC1N 3BG, United Kingdom

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jul 27, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02530580
Lead sponsor: University College, London
Responsible party: Sponsor
First posted: Aug 21, 2015
Start date: Feb 2016
Primary completion: Jul 2016
Completion: Jul 2016
Last update: Jul 27, 2016

Study contacts

Martin Koltzenburg, Prof

principal investigator · Institute of Neurology, University College London

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

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